GABAPENTIN
- Product NDC
- 59762-5050
- 11-digit product format
- 597625050
- Labeler code
- 59762
- Product ID
- 59762-5050_f5c6e992-4771-4c56-ac1f-00ccfb88bef5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA021129
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-07-01
- Substance
- GABAPENTIN
- Active strength
- 250 mg/5mL
- 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 | 250 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59762-5050-7 | GABAPENTIN | 470 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 470 | | 36 |
| 59762-5050-7 | GABAPENTIN | 1 in 1 CARTON | SUSPENSION | 1 | | 36 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] | 18 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59762-5050 | GABAPENTIN SUSPENSION [MYLAN PHARMACEUTICALS INC.] | 35 | Current NDC, Legacy NDC, 2 package rows | 20250503_cff7de45-148b-4e96-88fd-6052bf75b5f7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59762-5050-1 | 59762505001 | 1 BOTTLE in 1 CARTON (59762-5050-1) > 470 mL in 1 BOTTLE | 1 bottle | 2020-01-14 | 0000-00-00 | No | No | Current |
| 59762-5050-7 | 59762505007 | 1 BOTTLE, PLASTIC in 1 CARTON (59762-5050-7) / 470 mL in 1 BOTTLE, PLASTIC | | 2022-07-01 | 0000-00-00 | No | No | Current |