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MedsAcross

Medicine

Norco 325 mg/10 mg tablet

Acetaminophen and Hydrocodone · Oral · Direct_Rx
Available on requestPrescription onlyUS FDAControlled, schedule CII

Norco 325 mg/10 mg tablet is a prescription medicine containing Acetaminophen and Hydrocodone for oral use, marketed by Direct_Rx, 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). Protect from light. Store hydrocodone…

Key facts

Active ingredient (INN)
Acetaminophen and Hydrocodone
Brand
Norco
Strength
325 mg/10 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets, 60 tablets, 120 tablets and 1 more
Marketing authorisation holder
Direct_Rx
Manufacturer
Direct_Rx
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F). Protect from light. Store hydrocodone bitartrate and acetaminophen tablets securely and dispose of properly.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Schedule CII
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
23 November 2022
Identifiers
DailyMed set ID ee248dfd-7aa7-7dcc-e053-2995a90af19fNDC 72189-399Application ANDA040400

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

PackCodeLabelerMarketed since
30 tablet in 1 bottle72189-399-30Direct_Rx23 November 2022
60 tablet in 1 bottle72189-399-60Direct_Rx23 November 2022
120 tablet in 1 bottle72189-399-72Direct_Rx23 November 2022
90 tablet in 1 bottle72189-399-90Direct_Rx23 November 2022

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 FDAApprovedDrugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
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 Acetaminophen and Hydrocodone 325 mg/10 mg tablet.

Compare 1

Other strengths and forms of Acetaminophen and Hydrocodone

Clinical summary

Acetaminophen and Hydrocodone is a fixed-dose combination medicine indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. MedsAcross supplies Acetaminophen and Hydrocodone 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 Acetaminophen and Hydrocodone

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

Data sources

Need Norco 325 mg/10 mg tablet 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.