lioresal (baclofen)

Generic: baclofen

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lioresal (baclofen)
Generic Name baclofen
Labeler amneal pharmaceuticals llc
Dosage Form KIT
Routes
INTRATHECAL
Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-2501
Product ID 70121-2501_d68a08e0-d0d9-4144-be01-47b636dfa7e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020075
Listing Expiration 2026-12-31
Marketing Start 2022-06-12

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 701212501
Hyphenated Format 70121-2501

Supplemental Identifiers

RxCUI
308516 308517 805678 805679 1666613 1666620 1666622 1666623
UPC
0370121250319 0370121250524 0370121250227 0370121250425 0370121250111
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 lioresal (baclofen) (source: ndc)
Generic Name baclofen (source: ndc)
Application Number NDA020075 (source: ndc)
Routes
INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 0.05 mg/1 ml
  • 50 mcg/ml
  • 10 mg/20 ml
  • 500 mcg/ml
  • 10 mg/5 ml
  • 2000 mcg/ml
  • 40 mg/20 ml
source: label
Packaging
  • 1 AMPULE in 1 BOX (70121-2501-1) / 1 KIT in 1 AMPULE
source: ndc

Packages (1)

70121-2501-1 1 AMPULE in 1 BOX (70121-2501-1) / 1 KIT in 1 AMPULE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Lioresal (baclofen) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRATHECAL"], "spl_id": "d68a08e0-d0d9-4144-be01-47b636dfa7e1", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0370121250319", "0370121250524", "0370121250227", "0370121250425", "0370121250111"], "unii": ["H789N3FKE8"], "rxcui": ["308516", "308517", "805678", "805679", "1666613", "1666620", "1666622", "1666623"], "spl_set_id": ["6f3bdcc0-ffc8-4911-8c35-958c8103a2c5"], "pharm_class_epc": ["gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "pharm_class_moa": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 AMPULE in 1 BOX (70121-2501-1)  / 1 KIT in 1 AMPULE", "package_ndc": "70121-2501-1", "marketing_start_date": "20220612"}], "brand_name": "Lioresal (baclofen)", "product_id": "70121-2501_d68a08e0-d0d9-4144-be01-47b636dfa7e1", "dosage_form": "KIT", "product_ndc": "70121-2501", "generic_name": "baclofen", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lioresal (baclofen)", "application_number": "NDA020075", "marketing_category": "NDA", "marketing_start_date": "20220612", "listing_expiration_date": "20261231"}