Baclofen
- Product NDC
- 50090-5855
- 11-digit product format
- 500905855
- Labeler code
- 50090
- Product ID
- 50090-5855_fbe003fb-fb4f-4f3c-94ce-85d0a195f1b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA212378
- Marketing category
- ANDA
- Marketing start
- 2020-10-09
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-5855-0 | 2023-02-06 | C162847 | 48780-1 | f386c649-9e98-0266-e053-dadaa90a7c1a | f9488040-e570-4648-a47d-342a5430d58f |
| 50090-5855-1 | 2023-02-06 | C162847 | 48780-1 | f386c649-9e98-0266-e053-dadaa90a7c1a | f9488040-e570-4648-a47d-342a5430d58f |
| 50090-5855-3 | 2023-02-06 | C162847 | 48780-1 | f386c649-9e98-0266-e053-dadaa90a7c1a | f9488040-e570-4648-a47d-342a5430d58f |
| 50090-5855-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-9e98-0266-e053-dadaa90a7c1a | f9488040-e570-4648-a47d-342a5430d58f |
| 50090-5855-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-9e98-0266-e053-dadaa90a7c1a | f9488040-e570-4648-a47d-342a5430d58f |
| 50090-5855-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-9e98-0266-e053-dadaa90a7c1a | f9488040-e570-4648-a47d-342a5430d58f |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-5855-0 | EA - Each | 50090-5855 | 9c4edf13-69fa-490b-9116-9f0b85ed77c3 | 1 | 2022-06-06 |
| 50090-5855-1 | EA - Each | 50090-5855 | 2b71dbc5-699a-46e6-b7e8-62d6acc6374c | 1 | 2022-06-06 |
| 50090-5855-3 | EA - Each | 50090-5855 | a141401b-a70d-4826-9b00-723375ec6ea2 | 1 | 2022-06-06 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-5855-0 | 50090585500 | 60 TABLET in 1 BOTTLE (50090-5855-0) | 60 tablet | 2021-11-11 | 0000-00-00 | No | No | Current |
| 50090-5855-1 | 50090585501 | 30 TABLET in 1 BOTTLE (50090-5855-1) | 30 tablet | 2021-11-11 | 0000-00-00 | No | No | Current |
| 50090-5855-3 | 50090585503 | 90 TABLET in 1 BOTTLE (50090-5855-3) | 90 tablet | 2021-11-11 | 0000-00-00 | No | No | Current |