LYVISPAH
- Product NDC
- 64896-078
- 11-digit product format
- 648960078
- Labeler code
- 64896
- Product ID
- 64896-078_d042d45f-7097-47e0-921f-0442e00d47e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- NDA215422
- Marketing category
- NDA
- Marketing start
- 2023-06-01
- Substance
- BACLOFEN
- Active strength
- 20 mg/1
- Pharmacologic classes
- GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LYVISPAH
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACLOFEN | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 2586589, 2586595, 2586596, 2586598, 2586599, 2586601 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64896-078-09 | 64896007809 | 90 PACKET in 1 CARTON (64896-078-09) / 1 GRANULE in 1 PACKET | 90 packet | 2023-06-01 | No | No | Historical |