Gabapentin
- Product NDC
- 64725-0222
- 11-digit product format
- 647250222
- Labeler code
- 64725
- Product ID
- 64725-0222_dba983ee-133b-45c2-b552-c5e999b48980
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- 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 |
| 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 |
|---|---|---|---|---|---|
| 64725-0222-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4ae2-60a7-e053-dbdaa90a05bd | Gabapentin Capsules, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64725-0222-1 | Gabapentin | 100 in 1 BOTTLE | CAPSULE | 100 | 5 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN CAPSULE [TYA PHARMACEUTICALS] | 5 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN CAPSULE [TYA PHARMACEUTICALS] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | GABAPENTIN CAPSULE [TYA PHARMACEUTICALS] | 5 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | GABAPENTIN CAPSULE [TYA PHARMACEUTICALS] | 5 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | GABAPENTIN CAPSULE [TYA PHARMACEUTICALS] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN CAPSULE [TYA PHARMACEUTICALS] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN CAPSULE [TYA PHARMACEUTICALS] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN CAPSULE [TYA PHARMACEUTICALS] | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-0222 | GABAPENTIN CAPSULE [TYA PHARMACEUTICALS] | 5 | Legacy NDC, 1 package rows | 20140909_783d8373-b7af-4a6b-8966-50c5ddb2803b.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310430 | gabapentin 100 MG Oral Capsule | PSN | 783d8373-b7af-4a6b-8966-50c5ddb2803b | 5 |
| 310431 | gabapentin 300 MG Oral Capsule | PSN | 783d8373-b7af-4a6b-8966-50c5ddb2803b | 5 |
| 310430 | gabapentin 100 MG Oral Capsule | SCD | 783d8373-b7af-4a6b-8966-50c5ddb2803b | 5 |
| 310431 | gabapentin 300 MG Oral Capsule | SCD | 783d8373-b7af-4a6b-8966-50c5ddb2803b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 64725-0222-1 | 64725022201 | 100 in 1 BOTTLE | Historical |