Gabapentin
- Product NDC
- 0093-4443
- 11-digit product format
- 000934443
- Labeler code
- 0093
- Product ID
- 0093-4443_76e073b2-ef68-479a-938e-417338fc4105
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA076017
- Marketing category
- ANDA
- Marketing start
- 2008-07-11
- Marketing end
- 2019-05-31
- Substance
- GABAPENTIN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cdc2ae60-922e-452d-a42f-787fe4e2ed06 | Product name | 1 | 20250123 |
| 7059096a-4b9f-36c2-db50-bb5c723e6e9e | Product name | 2 | 20250114 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-4443-01 | EA - Each | 0093-4443 | ef0a706a-a8b3-427b-bd7c-ac99cc13d9a1 | 1 | 2012-07-24 |
| 0093-4443-05 | EA - Each | 0093-4443 | 47796a19-8ab1-47b8-8526-cf5dc16e7811 | 1 | 2012-07-24 |
| 0093-4443-10 | EA - Each | 0093-4443 | 1a1dbfc1-97a5-4b1f-9f05-d98e9afbc70b | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN TABLET [STAT RX USA LLC] | 3 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN TABLET [STAT RX USA LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GABAPENTIN TABLET [STAT RX USA LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GABAPENTIN TABLET [STAT RX USA LLC] | 3 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | GABAPENTIN TABLET [STAT RX USA LLC] | 3 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310433 | gabapentin 600 MG Oral Tablet | PSN | 998dcd24-c6f0-463c-9d13-e5c72b0e8fa0 | 3 |
| 310433 | gabapentin 600 MG Oral Tablet | SCD | 998dcd24-c6f0-463c-9d13-e5c72b0e8fa0 | 3 |