GABAPENTIN
- Product NDC
- 53002-2423
- 11-digit product format
- 530022423
- Labeler code
- 53002
- Product ID
- 53002-2423_58de486d-9931-4ee6-852e-9dfebc260a78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA090007
- Marketing category
- ANDA
- Marketing start
- 2015-12-30
- 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
- 2021-12-31
- 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 |
|---|
| 53002-2423-0 | GABAPENTIN | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
| 53002-2423-3 | GABAPENTIN | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
| 53002-2423-6 | GABAPENTIN | 60 in 1 BOTTLE | CAPSULE | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2423 | GABAPENTIN CAPSULE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 3 package rows | 20230609_d359f72b-dbf4-473f-8d1e-1e9a96179366.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-2423-0 | 53002242300 | 100 CAPSULE in 1 BOTTLE (53002-2423-0) | 100 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-2423-3 | 53002242303 | 30 CAPSULE in 1 BOTTLE (53002-2423-3) | 30 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-2423-6 | 53002242306 | 60 CAPSULE in 1 BOTTLE (53002-2423-6) | 60 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |