lyvispah

Generic: baclofen

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

Drug Facts

Product Profile

Brand Name lyvispah
Generic Name baclofen
Labeler amneal pharmaceuticals llc
Dosage Form GRANULE
Routes
ORAL
Active Ingredients

baclofen 20 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 64896-078
Product ID 64896-078_d042d45f-7097-47e0-921f-0442e00d47e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215422
Listing Expiration 2026-12-31
Marketing Start 2023-06-01

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 64896078
Hyphenated Format 64896-078

Supplemental Identifiers

RxCUI
2586589 2586595 2586596 2586598 2586599 2586601
UPC
0364896077097 0364896078094 0364896076090
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 lyvispah (source: ndc)
Generic Name baclofen (source: ndc)
Application Number NDA215422 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 PACKET in 1 CARTON (64896-078-09) / 1 GRANULE in 1 PACKET
source: ndc

Packages (1)

64896-078-09 90 PACKET in 1 CARTON (64896-078-09) / 1 GRANULE in 1 PACKET

Ingredients (1)

baclofen (20 mg/1)

Linked Drug Pages (1)

LYVISPAH ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d042d45f-7097-47e0-921f-0442e00d47e0", "openfda": {"nui": ["N0000000196", "N0000000116", "N0000175759"], "upc": ["0364896077097", "0364896078094", "0364896076090"], "unii": ["H789N3FKE8"], "rxcui": ["2586589", "2586595", "2586596", "2586598", "2586599", "2586601"], "spl_set_id": ["f8992a56-9010-4c4b-84d5-ddcc3e2c3317"], "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": "90 PACKET in 1 CARTON (64896-078-09)  / 1 GRANULE in 1 PACKET", "package_ndc": "64896-078-09", "marketing_start_date": "20230601"}], "brand_name": "LYVISPAH", "product_id": "64896-078_d042d45f-7097-47e0-921f-0442e00d47e0", "dosage_form": "GRANULE", "pharm_class": ["GABA A Agonists [MoA]", "GABA B Agonists [MoA]", "gamma-Aminobutyric Acid-ergic Agonist [EPC]"], "product_ndc": "64896-078", "generic_name": "baclofen", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LYVISPAH", "active_ingredients": [{"name": "BACLOFEN", "strength": "20 mg/1"}], "application_number": "NDA215422", "marketing_category": "NDA", "marketing_start_date": "20230601", "listing_expiration_date": "20261231"}