BACLOFEN
- Product NDC
- 73352-103
- 11-digit product format
- 733520103
- Labeler code
- 73352
- Product ID
- 73352-103_3a73197c-59cf-621b-e063-6394a90a955b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Trifluent Pharma, LLC
- Application
- ANDA214445
- Marketing category
- ANDA
- Marketing start
- 2025-06-05
- Substance
- BACLOFEN
- Active strength
- 5 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
- 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 | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 250976 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73352-103-16 | BACLOFEN | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 73352-103-16 | 73352010316 | 473 mL in 1 BOTTLE (73352-103-16) | 473 ml | 2025-06-05 | No | No | Current |