hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: strides pharma science limited
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 strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-440
Product ID 64380-440_eb9cfb36-9266-4334-b613-38153715a9bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202935
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2025-09-01

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380440
Hyphenated Format 64380-440

Supplemental Identifiers

RxCUI
856999 857002 857005
UPC
0364380440017 0364380441014 0364380442011
UNII
NO70W886KK 362O9ITL9D

Packaging Origin

Original Packager
true

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 ANDA202935 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64380-440-01)
source: ndc

Packages (1)

64380-440-01 100 TABLET in 1 BOTTLE (64380-440-01)

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": "eb9cfb36-9266-4334-b613-38153715a9bd", "openfda": {"upc": ["0364380440017", "0364380441014", "0364380442011"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002", "857005"], "spl_set_id": ["cc7f0a16-ff27-44d0-b69a-3f6aea1b993b"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64380-440-01)", "package_ndc": "64380-440-01", "marketing_start_date": "20250901"}], "brand_name": "hydrocodone bitartrate and acetaminophen", "product_id": "64380-440_eb9cfb36-9266-4334-b613-38153715a9bd", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "64380-440", "dea_schedule": "CII", "generic_name": "hydrocodone bitartrate and acetaminophen", "labeler_name": "Strides Pharma Science Limited", "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": "ANDA202935", "marketing_category": "ANDA", "marketing_start_date": "20250901", "listing_expiration_date": "20271231"}