Baclofen
- Product NDC
- 72834-602
- 11-digit product format
- 728340602
- Labeler code
- 72834
- Product ID
- 72834-602_47e27e4a-5ce3-113b-e063-6394a90a363d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Sarras Health LLC
- Application
- NDA208193
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-03-05
- Substance
- BACLOFEN
- Active strength
- 10 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
- 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 | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72834-602-16 | 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 |
|---|
| 72834-602 | BACLOFEN SOLUTION [SARRAS HEALTH LLC] | 1 | Current NDC, 1 package rows | 20240307_81a539b3-e547-4a62-ad1b-2eedb30be927.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 |
|---|
| 72834-602-16 | 72834060216 | 473 mL in 1 BOTTLE (72834-602-16) | 473 ml | 2024-03-05 | No | No | Current |