Baclofen
- Product NDC
- 71335-2669
- 11-digit product format
- 713352669
- Labeler code
- 71335
- Product ID
- 71335-2669_21d9a176-5277-4fa4-83c5-91ef3743368d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212378
- Marketing category
- ANDA
- Marketing start
- 2024-06-15
- 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 | 197392 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2669-1 | Baclofen | 100 in 1 BOTTLE | TABLET | 100 | | 100 |
| 71335-2669-2 | Baclofen | 1000 in 1 BOTTLE | TABLET | 1000 | | 100 |
| 71335-2669-3 | Baclofen | 120 in 1 BOTTLE | TABLET | 120 | | 100 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2669-1 | 71335266901 | 100 TABLET in 1 BOTTLE (71335-2669-1) | 100 tablet | 2025-06-26 | No | No | Historical |
| 71335-2669-2 | 71335266902 | 1000 TABLET in 1 BOTTLE (71335-2669-2) | 1000 tablet | 2025-06-26 | No | No | Historical |
| 71335-2669-3 | 71335266903 | 120 TABLET in 1 BOTTLE (71335-2669-3) | 120 tablet | 2025-06-26 | No | No | Historical |