Gabapentin
- Product NDC
- 42254-049
- 11-digit product format
- 422540049
- Labeler code
- 42254
- Product ID
- 42254-049_1bc85f95-c26a-4037-a02a-2248f6518fe2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA090705
- Marketing category
- ANDA
- Marketing start
- 2010-05-17
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 300 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cdc2ae60-922e-452d-a42f-787fe4e2ed06 | Product name | 1 | 20250123 |
| 7059096a-4b9f-36c2-db50-bb5c723e6e9e | Product name | 2 | 20250114 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42254-049-21 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d40-c013-e053-90daa90a1393 | Gabapentin Capsules, USP |
| 42254-049-30 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d40-c013-e053-90daa90a1393 | Gabapentin Capsules, USP |
| 42254-049-60 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d40-c013-e053-90daa90a1393 | Gabapentin Capsules, USP |
| 42254-049-72 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d40-c013-e053-90daa90a1393 | Gabapentin Capsules, USP |
| 42254-049-78 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d40-c013-e053-90daa90a1393 | Gabapentin Capsules, USP |
| 42254-049-90 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d40-c013-e053-90daa90a1393 | Gabapentin Capsules, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-049-21 | Gabapentin | 21 in 1 BOTTLE | CAPSULE | 21 | 1 | |
| 42254-049-30 | Gabapentin | 30 in 1 BOTTLE | CAPSULE | 30 | 1 | |
| 42254-049-60 | Gabapentin | 60 in 1 BOTTLE | CAPSULE | 60 | 1 | |
| 42254-049-72 | Gabapentin | 120 in 1 BOTTLE | CAPSULE | 120 | 1 | |
| 42254-049-78 | Gabapentin | 180 in 1 BOTTLE | CAPSULE | 180 | 1 | |
| 42254-049-90 | Gabapentin | 90 in 1 BOTTLE | CAPSULE | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42254-049-21 | EA - Each | 42254-049 | d661375b-b7ae-4486-b2df-4f4ff428beaf | 1 | 2012-07-24 |
| 42254-049-30 | EA - Each | 42254-049 | bd2c9cd9-daf5-453c-b5a5-8299fbb0a68d | 1 | 2012-07-24 |
| 42254-049-60 | EA - Each | 42254-049 | cb235019-3192-4798-80ca-ef3c9e222995 | 1 | 2012-07-24 |
| 42254-049-72 | EA - Each | 42254-049 | 3c95fb07-a884-4b0e-a53b-b83d0442cc98 | 1 | 2012-07-24 |
| 42254-049-78 | EA - Each | 42254-049 | 908f3c61-bd33-41b3-ad1c-746cdfc4e7c8 | 1 | 2012-07-24 |
| 42254-049-90 | EA - Each | 42254-049 | e6c88921-3e87-48a0-975b-dd8d9fc59fa7 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310431 | gabapentin 300 MG Oral Capsule | PSN | 1bc85f95-c26a-4037-a02a-2248f6518fe2 | 1 |
| 310431 | gabapentin 300 MG Oral Capsule | SCD | 1bc85f95-c26a-4037-a02a-2248f6518fe2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 42254-049-21 | 42254004921 | 21 in 1 BOTTLE | Historical |
| 42254-049-30 | 42254004930 | 30 in 1 BOTTLE | Historical |
| 42254-049-60 | 42254004960 | 60 in 1 BOTTLE | Historical |
| 42254-049-72 | 42254004972 | 120 in 1 BOTTLE | Historical |
| 42254-049-78 | 42254004978 | 180 in 1 BOTTLE | Historical |
| 42254-049-90 | 42254004990 | 90 in 1 BOTTLE | Historical |