Gabapentin
- Product NDC
- 10544-448
- 11-digit product format
- 105440448
- Labeler code
- 10544
- Product ID
- 10544-448_2adeb324-8a46-15aa-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA077662
- Marketing category
- ANDA
- Marketing start
- 2006-04-01
- 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
- 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 |
|---|
| 10544-448-02 | Gabapentin | 120 in 1 BOTTLE | TABLET | 120 | | 7 |
| 10544-448-90 | Gabapentin | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 6 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 6 | |
| COPOVIDONE K25-31 | INACTIVE INGREDIENT | D9C330MD8B | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 6 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 6 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 6 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-448 | GABAPENTIN TABLET [BLENHEIM PHARMACAL, INC.] | 7 | Legacy NDC, 2 package rows | 20160203_383fd4de-4d2a-42dc-9a15-48bee7efb0ba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-448-02 | 10544044802 | 120 in 1 BOTTLE | Historical |
| 10544-448-90 | 10544044890 | 90 in 1 BOTTLE | Historical |