GABAPENTIN
- Product NDC
- 43547-390
- 11-digit product format
- 435470390
- Labeler code
- 43547
- Product ID
- 43547-390_287538e6-6170-46b6-b209-6ae74b376b8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare U.S., LLC
- Application
- ANDA205101
- Marketing category
- ANDA
- Marketing start
- 2016-11-20
- Marketing end
- 2022-09-23
- 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
- 0000-00-00
- 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 |
|---|---|---|---|---|---|
| 43547-390-10 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d0-4270-f424-e053-dadaa90a57ce | 446e1edb-8e98-4627-879d-9bd7f33da50f |
| 43547-390-50 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d0-4270-f424-e053-dadaa90a57ce | 446e1edb-8e98-4627-879d-9bd7f33da50f |
| 43547-390-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4270-f424-e053-dadaa90a57ce | 446e1edb-8e98-4627-879d-9bd7f33da50f |
| 43547-390-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4270-f424-e053-dadaa90a57ce | 446e1edb-8e98-4627-879d-9bd7f33da50f |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-390-10 | EA - Each | 43547-390 | 34e72e06-7790-41d3-98cf-d79224a6a33d | 1 | 2017-11-06 |
| 43547-390-50 | EA - Each | 43547-390 | 4d4a89df-288b-402c-9bd6-daf12b6dbed2 | 1 | 2016-12-07 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310434 | gabapentin 800 MG Oral Tablet | PSN | a30a2645-75a9-dcd9-e053-2995a90a58e7 | 9 |
| 310434 | gabapentin 800 MG Oral Tablet | SCD | a30a2645-75a9-dcd9-e053-2995a90a58e7 | 9 |
| 310434 | gabapentin 800 MG Oral Tablet | PSN | d4d3459c-c19d-498d-9564-616f9ac8a72f | 3 |
| 310434 | gabapentin 800 MG Oral Tablet | SCD | d4d3459c-c19d-498d-9564-616f9ac8a72f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43547-390-10 | 43547039010 | 100 TABLET in 1 BOTTLE (43547-390-10) | 100 tablet | 2016-11-20 | 2022-09-23 | No | No | Current |
| 43547-390-50 | 43547039050 | 500 TABLET in 1 BOTTLE (43547-390-50) | 500 tablet | 2016-11-20 | 2022-09-23 | No | No | Current |