hydrocodone bitartrate and acetaminophen (0406-0378)

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and acetaminophen

Generic Name hydrocodone bitartrate and acetaminophen

Labeler specgx llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 300 mg/1, hydrocodone bitartrate 10 mg/1

Manufacturer

SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-0378

Product ID 0406-0378_1c335808-6b36-42f1-b811-284ac384d01a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA206718

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2017-03-31

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04060378

Hyphenated Format 0406-0378

Supplemental Identifiers

RxCUI

856980 856987 856992

UPC

0304060377059 0304060376052 0304060378056

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 ANDA206718 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1
10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (0406-0378-01)
500 TABLET in 1 BOTTLE (0406-0378-05)
1 TABLET in 1 BLISTER PACK (0406-0378-23)
10 BLISTER PACK in 1 CARTON (0406-0378-62) / 10 TABLET in 1 BLISTER PACK

source: ndc

Packages (4)

0406-0378-01 100 TABLET in 1 BOTTLE (0406-0378-01) 0406-0378-05 500 TABLET in 1 BOTTLE (0406-0378-05) 0406-0378-23 1 TABLET in 1 BLISTER PACK (0406-0378-23) 0406-0378-62 10 BLISTER PACK in 1 CARTON (0406-0378-62) / 10 TABLET in 1 BLISTER PACK

Ingredients (2)

acetaminophen (300 mg/1) hydrocodone bitartrate (10 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": "1c335808-6b36-42f1-b811-284ac384d01a", "openfda": {"upc": ["0304060377059", "0304060376052", "0304060378056"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856980", "856987", "856992"], "spl_set_id": ["d621b526-4d9a-48a9-9a3e-d29d6aea2f31"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-0378-01)", "package_ndc": "0406-0378-01", "marketing_start_date": "20170331"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0406-0378-05)", "package_ndc": "0406-0378-05", "marketing_start_date": "20170331"}, {"sample": false, "description": "1 TABLET in 1 BLISTER PACK (0406-0378-23)", "package_ndc": "0406-0378-23", "marketing_start_date": "20170331"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0406-0378-62)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "0406-0378-62", "marketing_start_date": "20170331"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "0406-0378_1c335808-6b36-42f1-b811-284ac384d01a", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0406-0378", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA206718", "marketing_category": "ANDA", "marketing_start_date": "20170331", "listing_expiration_date": "20261231"}