Gabapentin
- Product NDC
- 0093-4444
- 11-digit product format
- 000934444
- Labeler code
- 0093
- Product ID
- 0093-4444_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
- 2008-08-01
- Marketing end
- 2019-05-31
- Substance
- GABAPENTIN
- Active strength
- 800 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 |
|---|---|---|---|---|---|
| 0093-4444-01 | EA - Each | 0093-4444 | f7c28a3c-60dc-403d-a051-fc566747c2bd | 1 | 2012-07-24 |
| 0093-4444-05 | EA - Each | 0093-4444 | 42f886ec-0752-4f08-903f-54ed21efaefb | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN TABLET [UNIT DOSE SERVICES] | 3 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN TABLET [UNIT DOSE SERVICES] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GABAPENTIN TABLET [UNIT DOSE SERVICES] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GABAPENTIN TABLET [UNIT DOSE SERVICES] | 3 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | GABAPENTIN TABLET [UNIT DOSE SERVICES] | 3 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310434 | gabapentin 800 MG Oral Tablet | PSN | 6c554c68-7b9c-4863-beb2-a6a0aa45c61e | 7 |
| 310434 | gabapentin 800 MG Oral Tablet | SCD | 6c554c68-7b9c-4863-beb2-a6a0aa45c61e | 7 |