BACLOFEN
- Product NDC
- 68134-401
- 11-digit product format
- 681340401
- Labeler code
- 68134
- Product ID
- 68134-401_db4788b4-a23c-5ed7-e053-2995a90a48d1
- 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
- 2022-03-15
- Marketing end
- 0000-00-00
- Substance
- BACLOFEN
- Active strength
- 5 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68134-401-16 | 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 |
|---|
| 68134-401 | BACLOFEN SOLUTION [PALMETTO PHARMACEUTICALS INC.] | 2 | Legacy NDC, 1 package rows | 20220329_6cc2773b-cb64-48e9-a69b-e457b82cb2d4.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 |
|---|
| 68134-401-16 | 68134040116 | 473 mL in 1 BOTTLE (68134-401-16) | 473 ml | 2022-03-15 | 0000-00-00 | No | No | Current |