hydrocodone bitartrate and acetaminophen

Generic: hydrocodone bitartrate and acetaminophen

Labeler: lupin pharmaceuticals,inc.
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 lupin pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, hydrocodone bitartrate 10 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-358
Product ID 43386-358_2cb73d19-0ef9-4d59-a2de-b7b2b3a369a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206245
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-12-01

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386358
Hyphenated Format 43386-358

Supplemental Identifiers

RxCUI
856999 857002 857005
UPC
0343386357031 0343386358014 0343386356010
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 ANDA206245 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (43386-358-01)
  • 500 TABLET in 1 BOTTLE (43386-358-05)
  • 1000 TABLET in 1 BOTTLE (43386-358-10)
source: ndc

Packages (3)

43386-358-01 100 TABLET in 1 BOTTLE (43386-358-01) 43386-358-05 500 TABLET in 1 BOTTLE (43386-358-05) 43386-358-10 1000 TABLET in 1 BOTTLE (43386-358-10)

Ingredients (2)

acetaminophen (325 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": "2cb73d19-0ef9-4d59-a2de-b7b2b3a369a1", "openfda": {"upc": ["0343386357031", "0343386358014", "0343386356010"], "unii": ["NO70W886KK", "362O9ITL9D"], "rxcui": ["856999", "857002", "857005"], "spl_set_id": ["26a2178e-e0e5-4d61-81fd-e30a3142f1f2"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (43386-358-01)", "package_ndc": "43386-358-01", "marketing_start_date": "20161201"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43386-358-05)", "package_ndc": "43386-358-05", "marketing_start_date": "20161201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (43386-358-10)", "package_ndc": "43386-358-10", "marketing_start_date": "20161201"}], "brand_name": "Hydrocodone Bitartrate and Acetaminophen", "product_id": "43386-358_2cb73d19-0ef9-4d59-a2de-b7b2b3a369a1", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "43386-358", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Acetaminophen", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/1"}], "application_number": "ANDA206245", "marketing_category": "ANDA", "marketing_start_date": "20161201", "listing_expiration_date": "20261231"}