GABAPENTIN
- Product NDC
- 61919-843
- 11-digit product format
- 619190843
- Labeler code
- 61919
- Product ID
- 61919-843_9c9437d9-bfb8-2a03-e053-2a95a90aeded
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DirectRX
- Application
- ANDA202764
- Marketing category
- ANDA
- Marketing start
- 2015-11-25
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- 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 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-843-90 | 2023-01-30 | C162847 | 48780-1 | f386c649-dc93-0266-e053-dadaa90a7c1a | GABAPENTIN |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-843-90 | GABAPENTIN | 90 in 1 BOTTLE | TABLET | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-843-90 | EA - Each | 61919-843 | 80fa3c7a-ea6b-4ae2-b430-45100d4821a5 | 1 | 2016-04-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN TABLET [DIRECTRX] | 1 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN TABLET [DIRECTRX] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | GABAPENTIN TABLET [DIRECTRX] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | GABAPENTIN TABLET [DIRECTRX] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | GABAPENTIN TABLET [DIRECTRX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GABAPENTIN TABLET [DIRECTRX] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | GABAPENTIN TABLET [DIRECTRX] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | GABAPENTIN TABLET [DIRECTRX] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GABAPENTIN TABLET [DIRECTRX] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN TABLET [DIRECTRX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN TABLET [DIRECTRX] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310434 | gabapentin 800 MG Oral Tablet | PSN | 25621e62-d328-6479-e054-00144ff88e88 | 2 |
| 310434 | gabapentin 800 MG Oral Tablet | SCD | 25621e62-d328-6479-e054-00144ff88e88 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-843-90 | 61919084390 | 90 TABLET in 1 BOTTLE (61919-843-90) | 90 tablet | 2015-11-25 | 0000-00-00 | No | No | Current |