BACLOFEN
- Product NDC
- 59651-395
- 11-digit product format
- 596510395
- Labeler code
- 59651
- Product ID
- 59651-395_493c1b1f-7ee0-4a54-8e44-b2b015eb3850
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA214099
- Marketing category
- ANDA
- Marketing start
- 2021-07-13
- 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 | 197391, 197392 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-395-01 | BACLOFEN | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 59651-395-05 | BACLOFEN | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 59651-395-99 | 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 |
|---|
| 59651-395 | BACLOFEN TABLET [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, Legacy NDC, 3 package rows | 20211231_4679a275-9307-4b0f-a2eb-2d83227ea84d.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 |
|---|
| 59651-395-01 | 59651039501 | 100 TABLET in 1 BOTTLE (59651-395-01) | 100 tablet | 2021-07-13 | 0000-00-00 | No | No | Current |
| 59651-395-05 | 59651039505 | 500 TABLET in 1 BOTTLE (59651-395-05) | 500 tablet | 2021-07-13 | 0000-00-00 | No | No | Current |
| 59651-395-99 | 59651039599 | 1000 TABLET in 1 BOTTLE (59651-395-99) | 1000 tablet | 2021-07-13 | 0000-00-00 | No | No | Current |