Baclofen
- Product NDC
- 29300-343
- 11-digit product format
- 293000343
- Labeler code
- 29300
- Product ID
- 29300-343_513de439-4155-4a5d-a25c-bced499e293a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA212067
- Marketing category
- ANDA
- Marketing start
- 2020-07-09
- 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
- 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197391, 197392, 430902 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-343-01 | Baclofen | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 29300-343-05 | Baclofen | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
| 29300-343-10 | Baclofen | 1000 in 1 BOTTLE | TABLET | 1000 | | 6 |
| 29300-343-19 | Baclofen | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-343 | BACLOFEN TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20230615_b9199878-3fb4-46dc-adbb-b3d9dc3852d4.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 |
|---|
| 29300-343-01 | 29300034301 | 100 TABLET in 1 BOTTLE (29300-343-01) | 100 tablet | 2020-07-09 | 0000-00-00 | No | No | Current |
| 29300-343-05 | 29300034305 | 500 TABLET in 1 BOTTLE (29300-343-05) | 500 tablet | 2020-07-09 | 0000-00-00 | No | No | Current |
| 29300-343-10 | 29300034310 | 1000 TABLET in 1 BOTTLE (29300-343-10) | 1000 tablet | 2020-07-09 | 0000-00-00 | No | No | Current |
| 29300-343-19 | 29300034319 | 90 TABLET in 1 BOTTLE (29300-343-19) | 90 tablet | 2022-08-25 | 0000-00-00 | No | No | Current |