Gabapentin
- Product NDC
- 43353-731
- 11-digit product format
- 433530731
- Labeler code
- 43353
- Product ID
- 43353-731_63578037-37d7-4aff-8c75-da3338940c06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, Inc.
- Application
- ANDA090705
- Marketing category
- ANDA
- Marketing start
- 2010-05-17
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 100 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 |
|---|
| 43353-731-92 | Gabapentin | 270 in 1 BOTTLE, PLASTIC | CAPSULE | 270 | | 1 |
| 43353-731-98 | Gabapentin | 540 in 1 BOTTLE, PLASTIC | CAPSULE | 540 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-731 | GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | Legacy NDC, 2 package rows | 20121129_493e0603-8148-457b-a743-342f51c4c57a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-731-92 | 43353073192 | 270 in 1 BOTTLE, PLASTIC | Historical |
| 43353-731-98 | 43353073198 | 540 in 1 BOTTLE, PLASTIC | Historical |