Baclofen
- Product NDC
- 31722-998
- 11-digit product format
- 317220998
- Labeler code
- 31722
- Product ID
- 31722-998_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
- 10 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 31722-998-01 | 2026-01-29 | C162847 | 48780-1 | f386c649-aeb1-0266-e053-dadaa90a7c1a | Baclofen Tablets, USP Rx only |
| 31722-998-05 | 2026-01-29 | C162847 | 48780-1 | f386c649-aeb1-0266-e053-dadaa90a7c1a | Baclofen Tablets, USP Rx only |
| 31722-998-10 | 2026-01-29 | C162847 | 48780-1 | f386c649-aeb1-0266-e053-dadaa90a7c1a | Baclofen Tablets, USP Rx only |
| 31722-998-01 | 2023-10-11 | C162847 | 48780-1 | f386c649-aeb1-0266-e053-dadaa90a7c1a | Baclofen Tablets, USP Rx only |
| 31722-998-05 | 2023-10-11 | C162847 | 48780-1 | f386c649-aeb1-0266-e053-dadaa90a7c1a | Baclofen Tablets, USP Rx only |
| 31722-998-10 | 2023-10-11 | C162847 | 48780-1 | f386c649-aeb1-0266-e053-dadaa90a7c1a | Baclofen Tablets, USP Rx only |
| 31722-998-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-aeb1-0266-e053-dadaa90a7c1a | Baclofen Tablets, USP Rx only |
| 31722-998-05 | 2023-01-30 | C162847 | 48780-1 | f386c649-aeb1-0266-e053-dadaa90a7c1a | Baclofen Tablets, USP Rx only |
| 31722-998-10 | 2023-01-30 | C162847 | 48780-1 | f386c649-aeb1-0266-e053-dadaa90a7c1a | Baclofen Tablets, USP Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-998-01 | Baclofen | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 31722-998-05 | Baclofen | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 31722-998-10 | 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 |
|---|
| 31722-998 | BACLOFEN TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 3 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 |
|---|
| 31722-998-01 | 31722099801 | 100 TABLET in 1 BOTTLE (31722-998-01) | 100 tablet | 2020-10-15 | 0000-00-00 | No | No | Current |
| 31722-998-05 | 31722099805 | 500 TABLET in 1 BOTTLE (31722-998-05) | 500 tablet | 2020-10-15 | 0000-00-00 | No | No | Current |
| 31722-998-10 | 31722099810 | 1000 TABLET in 1 BOTTLE (31722-998-10) | 1000 tablet | 2020-10-15 | 0000-00-00 | No | No | Current |