hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen
Generic Name hydrocodone bitartrate and acetaminophen
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, hydrocodone bitartrate 5 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-396
Product ID 60687-396_2b5f781e-1360-0d65-e063-6294a90aa682
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210211
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-06-27

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687396
Hyphenated Format 60687-396

Supplemental Identifiers

RxCUI
856999 857002 857005
UNII
NO70W886KK 362O9ITL9D

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydrocodone bitartrate and acetaminophen (source: ndc)
Generic Name hydrocodone bitartrate and acetaminophen (source: ndc)
Application Number ANDA210211 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-396-01) / 1 TABLET in 1 BLISTER PACK (60687-396-11)
source: ndc

Packages (1)

60687-396-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-396-01) / 1 TABLET in 1 BLISTER PACK (60687-396-11)

Ingredients (2)

acetaminophen (325 mg/1) hydrocodone bitartrate (5 mg/1)

Linked Drug Pages (1)

Hydrocodone Bitartrate and Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b5f781e-1360-0d65-e063-6294a90aa682", "openfda": {"unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002", "857005"], "spl_set_id": ["9d76aaf6-e3e0-4ec1-9f20-3d5ab88de630"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-396-01)  / 1 TABLET in 1 BLISTER PACK (60687-396-11)", "package_ndc": "60687-396-01", "marketing_start_date": "20230627"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "60687-396_2b5f781e-1360-0d65-e063-6294a90aa682", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "60687-396", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA210211", "marketing_category": "ANDA", "marketing_start_date": "20230627", "listing_expiration_date": "20261231"}