GABAPENTIN
- Product NDC
- 43353-190
- 11-digit product format
- 433530190
- Labeler code
- 43353
- Product ID
- 43353-190_0fff2a2a-4229-4cef-9ea1-d0c63e9c2821
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gabapentin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA202764
- Marketing category
- ANDA
- Marketing start
- 2012-11-02
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 800 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 43353-190-45 | GABAPENTIN | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 6 |
| 43353-190-53 | GABAPENTIN | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
| 43353-190-60 | GABAPENTIN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
| 43353-190-70 | GABAPENTIN | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 6 |
| 43353-190-92 | GABAPENTIN | 270 in 1 BOTTLE | TABLET, FILM COATED | 270 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-190 | GABAPENTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 6 | Legacy NDC, 5 package rows | 20210124_11da2692-fb0a-4519-b8a4-323c7a6eeb4d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-190-45 | 43353019045 | 45 TABLET, FILM COATED in 1 BOTTLE (43353-190-45) | 2020-05-13 | 0000-00-00 | No | No | Current |
| 43353-190-53 | 43353019053 | 60 TABLET, FILM COATED in 1 BOTTLE (43353-190-53) | 2020-05-13 | 0000-00-00 | No | No | Current |
| 43353-190-60 | 43353019060 | 90 TABLET, FILM COATED in 1 BOTTLE (43353-190-60) | 2020-12-09 | 0000-00-00 | No | No | Current |
| 43353-190-70 | 43353019070 | 120 TABLET, FILM COATED in 1 BOTTLE (43353-190-70) | 2017-11-22 | 0000-00-00 | No | No | Current |
| 43353-190-92 | 43353019092 | 270 TABLET, FILM COATED in 1 BOTTLE (43353-190-92) | 2016-06-25 | 0000-00-00 | No | No | Current |