Gabapentin
- Product NDC
- 55289-959
- 11-digit product format
- 552890959
- Labeler code
- 55289
- Product ID
- 55289-959_3892af8e-2138-00ac-e063-6394a90a516f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077662
- Marketing category
- ANDA
- Marketing start
- 2006-04-01
- Substance
- GABAPENTIN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gabapentin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GABAPENTIN | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310433 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55289-959-30 | Gabapentin | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 26 |
| 55289-959-60 | Gabapentin | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 26 |
| 55289-959-90 | Gabapentin | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 26 |
| 55289-959-98 | Gabapentin | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| COPOVIDONE | INACTIVE INGREDIENT | D9C330MD8B | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-959 | GABAPENTIN TABLET [PD-RX PHARMACEUTICALS, INC.] | 25 | Current NDC, Legacy NDC, 4 package rows | 20250316_7c3b232a-3e9f-4249-9e5a-295482ee288a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55289-959-30 | 55289095930 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-959-30) | 30 tablet | 2020-01-27 | 0000-00-00 | No | No | Current |
| 55289-959-60 | 55289095960 | 60 TABLET in 1 BOTTLE, PLASTIC (55289-959-60) | 60 tablet | 2011-10-10 | 0000-00-00 | No | No | Current |
| 55289-959-90 | 55289095990 | 90 TABLET in 1 BOTTLE, PLASTIC (55289-959-90) | 90 tablet | 2011-10-10 | 0000-00-00 | No | No | Current |
| 55289-959-98 | 55289095998 | 120 TABLET in 1 BOTTLE, PLASTIC (55289-959-98) | 120 tablet | 2011-10-10 | 0000-00-00 | No | No | Current |