BACLOFEN
- Product NDC
- 68788-8575
- 11-digit product format
- 687888575
- Labeler code
- 68788
- Product ID
- 68788-8575_7cc63960-14f2-47ce-80f7-fe5df62d634a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA214099
- Marketing category
- ANDA
- Marketing start
- 2024-02-28
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BACLOFEN
- Listing expiration
- 2027-12-31
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 |
|---|
| 68788-8575-3 | BACLOFEN | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 68788-8575-9 | BACLOFEN | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8575 | BACLOFEN TABLET [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 2 package rows | 20250126_9bd46eb6-53b2-4845-88b4-81c1ced08aaa.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 |
|---|
| 68788-8575-3 | 68788857503 | 30 TABLET in 1 BOTTLE (68788-8575-3) | 30 tablet | 2024-02-28 | No | No | Historical |
| 68788-8575-9 | 68788857509 | 90 TABLET in 1 BOTTLE (68788-8575-9) | 90 tablet | 2024-02-28 | No | No | Historical |