Gabapentin
- Product NDC
- 10135-647
- 11-digit product format
- 101350647
- Labeler code
- 10135
- Product ID
- 10135-647_d178699e-2910-b747-e053-2a95a90a9de3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA205101
- Marketing category
- ANDA
- Marketing start
- 2018-04-01
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 600 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 10135-647-01 | 2023-01-30 | C162847 | 48780-1 | 9d75b9cf-f90e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93 |
| 10135-647-05 | 2023-01-30 | C162847 | 48780-1 | 9d75b9cf-f90e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93 |
| 10135-647-01 | 2021-11-23 | C162847 | 48780-1 | 9d75b9cf-f90e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93 |
| 10135-647-05 | 2021-11-23 | C162847 | 48780-1 | 9d75b9cf-f90e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93 |
| 10135-647-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f90e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93 |
| 10135-647-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f90e-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-647-01 | Gabapentin | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 10135-647-05 | Gabapentin | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-647 | GABAPENTIN TABLET [MARLEX PHARMACEUTICALS INC] | 3 | Legacy NDC, 2 package rows | 20211124_e28c6b45-4624-4c48-95e7-cb2d2404f70b.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 |
|---|
| 10135-647-01 | 10135064701 | 100 TABLET in 1 BOTTLE (10135-647-01) | 100 tablet | 2018-04-01 | 0000-00-00 | No | No | Current |
| 10135-647-05 | 10135064705 | 500 TABLET in 1 BOTTLE (10135-647-05) | 500 tablet | 2018-04-01 | 0000-00-00 | No | No | Current |