Baclofen
- Product NDC
- 68134-403
- 11-digit product format
- 681340403
- Labeler code
- 68134
- Product ID
- 68134-403_47426f2f-4630-5a83-e063-6294a90a88d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Palmetto Pharmaceuticals Inc.
- Application
- NDA208193
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-09-25
- Substance
- BACLOFEN
- Active strength
- 10 mg/5mL
- 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
- Baclofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACLOFEN | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 2667941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68134-403-16 | Baclofen | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68134-403 | BACLOFEN SOLUTION [PALMETTO PHARMACEUTICALS INC.] | 1 | Current NDC, 1 package rows | 20241012_2422746c-afec-ad30-e063-6394a90a0403.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68134-403-16 | 68134040316 | 473 mL in 1 BOTTLE (68134-403-16) | 473 ml | 2024-09-25 | No | No | Current |