GABAPENTIN
- Product NDC
- 21695-058
- 11-digit product format
- 216950058
- Labeler code
- 21695
- Product ID
- 21695-058_95ceac2d-ce96-4d9d-9fe6-893940f1decb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA077525
- Marketing category
- ANDA
- Marketing start
- 2006-08-24
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-058-30 | GABAPENTIN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 21695-058-60 | GABAPENTIN | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 21695-058-90 | GABAPENTIN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| GLYCERYL BEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-058 | GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | Legacy NDC, 3 package rows | 20091208_2fe659eb-a8b4-491b-9195-fe979d7f0373.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-058-30 | 21695005830 | 30 in 1 BOTTLE | Historical |
| 21695-058-60 | 21695005860 | 60 in 1 BOTTLE | Historical |
| 21695-058-90 | 21695005890 | 90 in 1 BOTTLE | Historical |