BACLOFEN
- Product NDC
- 84386-035
- 11-digit product format
- 843860035
- Labeler code
- 84386
- Product ID
- 84386-035_f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACLOFEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA214099
- Marketing category
- ANDA
- Marketing start
- 2025-11-21
- Substance
- BACLOFEN
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 430902 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84386-035-01 | BACLOFEN | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84386-035-01 | 84386003501 | 100 TABLET in 1 BOTTLE (84386-035-01) | 100 tablet | 2025-11-21 | No | No | Current |
| 84386-035-93 | 84386003593 | 9000 TABLET in 1 BAG (84386-035-93) | 9000 tablet | 21-NOV-25 | | | Current |