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Medicine

Buprenorphine 7.5 mcg/hour transdermal patch

Buprenorphine · Transdermal
Available on requestPrescription onlyUS FDAControlled, schedule CIIIGeneric name

Buprenorphine 7.5 mcg/hour transdermal patch is a generic prescription medicine for transdermal use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…

Key facts

Active ingredient (INN)
Buprenorphine
Brand
Sold under the generic name
Strength
7.5 mcg/hour
Dosage form
Transdermal patch
Route
Transdermal
Packs
4 pouches and 2 more
Manufacturers
Amneal Pharmaceuticals NYAveva Drug Delivery SystemsIngenus PharmaceuticalsRhodes PharmaceuticalsTeva Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Store buprenorphine transdermal systems securely and dispose of properly.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Schedule CIII
ATC code
N02AE01 Buprenorphine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
3 July 2017
Identifiers
RxCUI 904870, 904876, 904880 +2DailyMed set ID c7d079fb-507f-436f-b794-2171b7d97067, 36995ce3-b515-447b-baa9-aa14f84060d8, 186e3be6-8bc0-4bb9-96f5-429d53632f45 +2NDC 69238-1505, 0093-3239, 50742-373 +2Application ANDA211586, ANDA204937, ANDA210272 +1

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
4 pouch in 1 carton / 1 patch in 1 pouch / 168 h in 1 patch69238-1505-2Amneal Pharmaceuticals NY20 April 2020
4 pouch in 1 carton / 1 patch in 1 pouch / 168 h in 1 patch3215-1522-04Aveva Drug Delivery Systems1 November 2023
4 pouch in 1 carton / 1 patch in 1 pouch / 168 h in 1 patch50742-373-04Ingenus Pharmaceuticals1 November 2023
4 pouch in 1 carton / 1 patch in 1 pouch / 168 h in 1 patch42858-353-40Rhodes Pharmaceuticals5 July 2017
4 pouch in 1 carton / 1 patch in 1 pouch / 168 h in 1 patch0093-3239-40Teva Pharmaceuticals27 December 2021

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 29 December 1981Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Buprenorphine 7.5 mcg/hour transdermal patch.

Compare 1

Other strengths and forms of Buprenorphine

Clinical summary

Buprenorphine is a partial opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids, among other approved uses. MedsAcross supplies Buprenorphine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Buprenorphine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Buprenorphine 7.5 mcg/hour transdermal patch for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.