Baclofen
- Product NDC
- 50268-105
- 11-digit product format
- 502680105
- Labeler code
- 50268
- Product ID
- 50268-105_2b489a19-55e7-8503-e063-6294a90aa6e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA211659
- Marketing category
- ANDA
- Marketing start
- 2021-05-11
- Substance
- BACLOFEN
- Active strength
- 5 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
- Baclofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACLOFEN | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 430902 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-105-11 | Baclofen | 1 in 1 BLISTER PACK | TABLET | 1 | | 4 |
| 50268-105-15 | Baclofen | 50 in 1 BOX | TABLET | 50 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-105 | BACLOFEN TABLET [AVPAK] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250112_c21095a9-17b1-555a-e053-2a95a90a51fd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50268-105-11 | 50268010511 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-105-15 | 50268010515 | 50 BLISTER PACK in 1 BOX (50268-105-15) / 1 TABLET in 1 BLISTER PACK (50268-105-11) | 50 blister pack | 2021-05-11 | 0000-00-00 | No | No | Current |