baclofen

Generic: baclofen

Labeler: mala pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name baclofen
Generic Name baclofen
Labeler mala pharmaceuticals, inc.
Dosage Form INJECTION
Routes
INTRATHECAL
Active Ingredients

baclofen 50 ug/mL

Manufacturer
MAlA Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70511-121
Product ID 70511-121_58150ebf-c2d6-49be-a519-06d839637462
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210777
Listing Expiration 2026-12-31
Marketing Start 2021-04-02

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 70511121
Hyphenated Format 70511-121

Supplemental Identifiers

RxCUI
1047437
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 ANDA210777 (source: ndc)
Routes
INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 50 ug/mL
source: ndc
Packaging
  • 2 SYRINGE, GLASS in 1 CARTON (70511-121-80) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

70511-121-80 2 SYRINGE, GLASS in 1 CARTON (70511-121-80) / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

baclofen (50 ug/mL)

Linked Drug Pages (1)

Baclofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRATHECAL"], "spl_id": "58150ebf-c2d6-49be-a519-06d839637462", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "unii": ["H789N3FKE8"], "rxcui": ["1047437"], "spl_set_id": ["e05080ef-53d9-4060-aaa4-86a6935467de"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["MAlA Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (70511-121-80)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "70511-121-80", "marketing_start_date": "20220601"}], "brand_name": "Baclofen", "product_id": "70511-121_58150ebf-c2d6-49be-a519-06d839637462", "dosage_form": "INJECTION", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "70511-121", "generic_name": "Baclofen", "labeler_name": "MAlA Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Baclofen", "active_ingredients": [{"name": "BACLOFEN", "strength": "50 ug/mL"}], "application_number": "ANDA210777", "marketing_category": "ANDA", "marketing_start_date": "20210402", "listing_expiration_date": "20261231"}