Gabapentin
- Product NDC
- 58517-060
- 11-digit product format
- 585170060
- Labeler code
- 58517
- Product ID
- 58517-060_01e45240-dc37-486b-8451-2b5e5a12cfdd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- New Horizon Rx Group, LLC
- Application
- ANDA078787
- Marketing category
- ANDA
- Marketing start
- 2013-08-25
- 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
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 58517-060-30 | Gabapentin | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GABAPENTIN | ACTIVE INGREDIENT | 6CW7F3G59X | GABAPENTIN CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| GABAPENTIN | ACTIVE MOIETY | 6CW7F3G59X | GABAPENTIN CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GABAPENTIN CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | GABAPENTIN CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | GABAPENTIN CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | GABAPENTIN CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | GABAPENTIN CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GABAPENTIN CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | GABAPENTIN CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GABAPENTIN CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58517-060 | GABAPENTIN CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | Legacy NDC, 1 package rows | 20131231_b846004f-a71d-4ebe-a1aa-1f9b6ac89ee0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 58517-060-30 | 58517006030 | 30 in 1 BOTTLE | Historical |