baclofen

Generic: baclofen

Labeler: lifestar pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler lifestar pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

baclofen 20 mg/1

Manufacturer
Lifestar Pharma LLC

Identifiers & Regulatory

Product NDC 70756-289
Product ID 70756-289_97901dd3-f1e0-4fc8-86a1-5114e2095073
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215885
Listing Expiration 2027-12-31
Marketing Start 2022-01-26

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 70756289
Hyphenated Format 70756-289

Supplemental Identifiers

RxCUI
197391 197392 430902
UPC
0370756288121 0370756289517 0370756288114 0370756288992 0370756289111
UNII
H789N3FKE8
NUI
N0000000196 N0000000116 N0000175759

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 baclofen (source: ndc)
Generic Name baclofen (source: ndc)
Application Number ANDA215885 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70756-289-11)
  • 1000 TABLET in 1 BOTTLE (70756-289-12)
  • 500 TABLET in 1 BOTTLE (70756-289-51)
  • 10 BLISTER PACK in 1 CARTON (70756-289-99) / 10 TABLET in 1 BLISTER PACK (70756-289-01)
source: ndc

Packages (4)

70756-289-11 100 TABLET in 1 BOTTLE (70756-289-11) 70756-289-12 1000 TABLET in 1 BOTTLE (70756-289-12) 70756-289-51 500 TABLET in 1 BOTTLE (70756-289-51) 70756-289-99 10 BLISTER PACK in 1 CARTON (70756-289-99) / 10 TABLET in 1 BLISTER PACK (70756-289-01)

Ingredients (1)

baclofen (20 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": "97901dd3-f1e0-4fc8-86a1-5114e2095073", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0370756288121", "0370756289517", "0370756288114", "0370756288992", "0370756289111"], "unii": ["H789N3FKE8"], "rxcui": ["197391", "197392", "430902"], "spl_set_id": ["f9dd1b55-2984-446a-8146-2ab0f5211e15"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Lifestar Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70756-289-11)", "package_ndc": "70756-289-11", "marketing_start_date": "20220126"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (70756-289-12)", "package_ndc": "70756-289-12", "marketing_start_date": "20220126"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70756-289-51)", "package_ndc": "70756-289-51", "marketing_start_date": "20220126"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70756-289-99)  / 10 TABLET in 1 BLISTER PACK (70756-289-01)", "package_ndc": "70756-289-99", "marketing_start_date": "20240325"}], "brand_name": "Baclofen", "product_id": "70756-289_97901dd3-f1e0-4fc8-86a1-5114e2095073", "dosage_form": "TABLET", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "70756-289", "generic_name": "Baclofen", "labeler_name": "Lifestar Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "ANDA215885", "marketing_category": "ANDA", "marketing_start_date": "20220126", "listing_expiration_date": "20271231"}