Baclofen
- Product NDC
- 71205-474
- 11-digit product format
- 712050474
- Labeler code
- 71205
- Product ID
- 71205-474_4702c59e-202c-4900-9388-f64788cb035c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078504
- Marketing category
- ANDA
- Marketing start
- 2011-01-01
- Substance
- BACLOFEN
- Active strength
- 10 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| H789N3FKE8 | BACLOFEN | 1134-47-0 | BACLOFEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-474-14 | 71205047414 | 14 TABLET in 1 BOTTLE (71205-474-14) | 14 tablet | 2022-01-05 | No | No | Historical |
| 71205-474-20 | 71205047420 | 20 TABLET in 1 BOTTLE (71205-474-20) | 20 tablet | 2020-10-01 | No | No | Historical |
| 71205-474-30 | 71205047430 | 30 TABLET in 1 BOTTLE (71205-474-30) | 30 tablet | 2020-08-27 | No | No | Historical |
| 71205-474-60 | 71205047460 | 60 TABLET in 1 BOTTLE (71205-474-60) | 60 tablet | 2020-08-27 | No | No | Historical |
| 71205-474-72 | 71205047472 | 120 TABLET in 1 BOTTLE (71205-474-72) | 120 tablet | 2020-12-22 | No | No | Historical |
| 71205-474-78 | 71205047478 | 180 TABLET in 1 BOTTLE (71205-474-78) | 180 tablet | 2020-09-25 | No | No | Historical |
| 71205-474-90 | 71205047490 | 90 TABLET in 1 BOTTLE (71205-474-90) | 90 tablet | 2020-08-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rx Only | Proficient Rx LP | 2022-03-01 | HUMAN PRESCRIPTION DRUG LABEL | 5 |