BACLOFEN
- Product NDC
- 70518-4290
- 11-digit product format
- 705184290
- Labeler code
- 70518
- Product ID
- 70518-4290_401bf8ec-a614-cce6-e063-6294a90ac723
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209102
- Marketing category
- ANDA
- Marketing start
- 2025-02-15
- 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
- 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197392 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4290-0 | BACLOFEN | 30 in 1 BLISTER PACK | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4290 | BACLOFEN TABLET [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20250221_4e2cd27d-91c7-4f15-96cc-3971769dbeaa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4290-0 | 70518429000 | 30 TABLET in 1 BLISTER PACK (70518-4290-0) | 30 tablet | 2025-02-15 | No | No | Historical |