Baclofen
- Product NDC
- 50268-107
- 11-digit product format
- 502680107
- Labeler code
- 50268
- Product ID
- 50268-107_5128fbd5-ce74-2c6a-e063-6294a90ad95f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA211659
- Marketing category
- ANDA
- Marketing start
- 2021-03-02
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Baclofen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACLOFEN | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197391, 197392 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-107-11 | Baclofen | 1 in 1 BLISTER PACK | TABLET | 1 | | 5 |
| 50268-107-15 | Baclofen | 50 in 1 BOX | TABLET | 50 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-107 | BACLOFEN TABLET [AVPAK] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250112_bc9040d9-1c54-9d62-e053-2a95a90a6ae3.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 |
|---|
| 50268-107-11 | 50268010711 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-107-15 | 50268010715 | 50 BLISTER PACK in 1 BOX (50268-107-15) / 1 TABLET in 1 BLISTER PACK (50268-107-11) | 50 blister pack | 2021-03-02 | 0000-00-00 | No | No | Current |