Gabapentin
- Product NDC
- 42495-266
- 11-digit product format
- 424950266
- Labeler code
- 42495
- Product ID
- 42495-266_9e656733-a7aa-43d2-b11f-e87f6e15d64d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- MSM Repackaging
- Application
- ANDA090007
- Marketing category
- ANDA
- Marketing start
- 2012-10-15
- 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 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42495-266-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7b25-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Gabapentin capsules safely and effectively. See full prescribing information for gabapentin capsules. Gabapentin Capsules, USP for oral use Initial U.S. Approval: 1993 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42495-266-30 | Gabapentin | 30 in 1 BLISTER PACK | CAPSULE | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN CAPSULE [MSM REPACKAGING ] | 1 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN CAPSULE [MSM REPACKAGING ] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | GABAPENTIN CAPSULE [MSM REPACKAGING ] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GABAPENTIN CAPSULE [MSM REPACKAGING ] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | GABAPENTIN CAPSULE [MSM REPACKAGING ] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GABAPENTIN CAPSULE [MSM REPACKAGING ] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | GABAPENTIN CAPSULE [MSM REPACKAGING ] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | GABAPENTIN CAPSULE [MSM REPACKAGING ] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN CAPSULE [MSM REPACKAGING ] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN CAPSULE [MSM REPACKAGING ] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN CAPSULE [MSM REPACKAGING ] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310431 | gabapentin 300 MG Oral Capsule | PSN | b7cf18b4-f114-434b-9a4c-0c40b1a2b47d | 1 |
| 310431 | gabapentin 300 MG Oral Capsule | SCD | b7cf18b4-f114-434b-9a4c-0c40b1a2b47d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 42495-266-30 | 42495026630 | 30 in 1 BLISTER PACK | Historical |