Baclofen
- Product NDC
- 31722-138
- 11-digit product format
- 317220138
- Labeler code
- 31722
- Product ID
- 31722-138_896572e4-f389-4b66-9a0b-4b83e71481b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA212378
- Marketing category
- ANDA
- Marketing start
- 2020-10-09
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-138-01 | Baclofen | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 31722-138-10 | Baclofen | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-138 | BACLOFEN TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 2 package rows | 20231012_ce48b5de-92d3-424e-ba70-c1f2edb28f66.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 |
|---|
| 31722-138-01 | 31722013801 | 100 TABLET in 1 BOTTLE (31722-138-01) | 100 tablet | 2020-10-15 | 0000-00-00 | No | No | Current |
| 31722-138-10 | 31722013810 | 1000 TABLET in 1 BOTTLE (31722-138-10) | 1000 tablet | 2020-10-15 | 0000-00-00 | No | No | Current |