baclofen

Generic: baclofen

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2767
Product ID 71335-2767_5bae76d2-2bf4-4353-ac07-0156403a7cf1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212378
Listing Expiration 2026-12-31
Marketing Start 2024-06-15

Pharmacologic Class

Established (EPC)
gamma-aminobutyric acid-ergic agonist [epc]
Mechanism of Action
gaba a agonists [moa] gaba b agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713352767
Hyphenated Format 71335-2767

Supplemental Identifiers

RxCUI
197391
UNII
H789N3FKE8
NUI
N0000000196 N0000000116 N0000175759

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 baclofen (source: ndc)
Generic Name baclofen (source: ndc)
Application Number ANDA212378 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 112 TABLET in 1 BLISTER PACK (71335-2767-0)
  • 30 TABLET in 1 BLISTER PACK (71335-2767-1)
  • 120 TABLET in 1 BLISTER PACK (71335-2767-2)
  • 20 TABLET in 1 BLISTER PACK (71335-2767-3)
  • 60 TABLET in 1 BLISTER PACK (71335-2767-4)
  • 100 TABLET in 1 BLISTER PACK (71335-2767-5)
  • 56 TABLET in 1 BLISTER PACK (71335-2767-6)
  • 90 TABLET in 1 BLISTER PACK (71335-2767-7)
  • 140 TABLET in 1 BLISTER PACK (71335-2767-8)
  • 84 TABLET in 1 BLISTER PACK (71335-2767-9)
source: ndc

Packages (10)

71335-2767-0 112 TABLET in 1 BLISTER PACK (71335-2767-0) 71335-2767-1 30 TABLET in 1 BLISTER PACK (71335-2767-1) 71335-2767-2 120 TABLET in 1 BLISTER PACK (71335-2767-2) 71335-2767-3 20 TABLET in 1 BLISTER PACK (71335-2767-3) 71335-2767-4 60 TABLET in 1 BLISTER PACK (71335-2767-4) 71335-2767-5 100 TABLET in 1 BLISTER PACK (71335-2767-5) 71335-2767-6 56 TABLET in 1 BLISTER PACK (71335-2767-6) 71335-2767-7 90 TABLET in 1 BLISTER PACK (71335-2767-7) 71335-2767-8 140 TABLET in 1 BLISTER PACK (71335-2767-8) 71335-2767-9 84 TABLET in 1 BLISTER PACK (71335-2767-9)

Ingredients (1)

baclofen (10 mg/1)

Linked Drug Pages (1)

Baclofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5bae76d2-2bf4-4353-ac07-0156403a7cf1", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["197391"], "spl_set_id": ["0a5940cd-63eb-4d1b-8e92-44df264bc05a"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "112 TABLET in 1 BLISTER PACK (71335-2767-0)", "package_ndc": "71335-2767-0", "marketing_start_date": "20251003"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (71335-2767-1)", "package_ndc": "71335-2767-1", "marketing_start_date": "20251003"}, {"sample": false, "description": "120 TABLET in 1 BLISTER PACK (71335-2767-2)", "package_ndc": "71335-2767-2", "marketing_start_date": "20251003"}, {"sample": false, "description": "20 TABLET in 1 BLISTER PACK (71335-2767-3)", "package_ndc": "71335-2767-3", "marketing_start_date": "20251003"}, {"sample": false, "description": "60 TABLET in 1 BLISTER PACK (71335-2767-4)", "package_ndc": "71335-2767-4", "marketing_start_date": "20251003"}, {"sample": false, "description": "100 TABLET in 1 BLISTER PACK (71335-2767-5)", "package_ndc": "71335-2767-5", "marketing_start_date": "20251003"}, {"sample": false, "description": "56 TABLET in 1 BLISTER PACK (71335-2767-6)", "package_ndc": "71335-2767-6", "marketing_start_date": "20251003"}, {"sample": false, "description": "90 TABLET in 1 BLISTER PACK (71335-2767-7)", "package_ndc": "71335-2767-7", "marketing_start_date": "20251003"}, {"sample": false, "description": "140 TABLET in 1 BLISTER PACK (71335-2767-8)", "package_ndc": "71335-2767-8", "marketing_start_date": "20251003"}, {"sample": false, "description": "84 TABLET in 1 BLISTER PACK (71335-2767-9)", "package_ndc": "71335-2767-9", "marketing_start_date": "20251003"}], "brand_name": "Baclofen", "product_id": "71335-2767_5bae76d2-2bf4-4353-ac07-0156403a7cf1", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "71335-2767", "generic_name": "Baclofen", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "10 mg/1"}], "application_number": "ANDA212378", "marketing_category": "ANDA", "marketing_start_date": "20240615", "listing_expiration_date": "20261231"}