Gabapentin
- Product NDC
- 43547-266
- 11-digit product format
- 435470266
- Labeler code
- 43547
- Product ID
- 43547-266_65acdb4c-8966-4fcd-ba81-69fea6473f25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Solco Healthcare U.S., LLC
- Application
- ANDA090007
- Marketing category
- ANDA
- Marketing start
- 2012-10-15
- Marketing end
- 2020-09-01
- Substance
- GABAPENTIN
- Active strength
- 300 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|---|---|---|---|---|
| 43547-266-03 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-540a-f424-e053-dadaa90a57ce | 9e722109-1eef-40c2-8e93-46ef9fb42029 |
| 43547-266-10 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-540a-f424-e053-dadaa90a57ce | 9e722109-1eef-40c2-8e93-46ef9fb42029 |
| 43547-266-50 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-540a-f424-e053-dadaa90a57ce | 9e722109-1eef-40c2-8e93-46ef9fb42029 |
| 43547-266-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-540a-f424-e053-dadaa90a57ce | 9e722109-1eef-40c2-8e93-46ef9fb42029 |
| 43547-266-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-540a-f424-e053-dadaa90a57ce | 9e722109-1eef-40c2-8e93-46ef9fb42029 |
| 43547-266-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-540a-f424-e053-dadaa90a57ce | 9e722109-1eef-40c2-8e93-46ef9fb42029 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-266-10 | EA - Each | 43547-266 | 406b108e-5273-4227-b701-9fd4ccd25c11 | 1 | 2014-01-04 |
| 43547-266-50 | EA - Each | 43547-266 | a7937718-3021-4dba-bd8b-c24d1cbb5cca | 1 | 2014-01-04 |
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 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 |