GABAPENTIN
- Product NDC
- 43547-383
- 11-digit product format
- 435470383
- Labeler code
- 43547
- Product ID
- 43547-383_287538e6-6170-46b6-b209-6ae74b376b8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Solco Healthcare U.S., LLC
- Application
- ANDA204989
- Marketing category
- ANDA
- Marketing start
- 2016-09-30
- Marketing end
- 2022-07-10
- Substance
- GABAPENTIN
- Active strength
- 100 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 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| fa3f0129-3502-889f-f424-3a37727959e7 | Product name | 9 | 20181206 |
| 77d89e4c-f57f-326d-d7aa-787f8eebbd2b | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43547-383-03 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d0-4270-f424-e053-dadaa90a57ce | 446e1edb-8e98-4627-879d-9bd7f33da50f |
| 43547-383-10 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d0-4270-f424-e053-dadaa90a57ce | 446e1edb-8e98-4627-879d-9bd7f33da50f |
| 43547-383-11 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d0-4270-f424-e053-dadaa90a57ce | 446e1edb-8e98-4627-879d-9bd7f33da50f |
| 43547-383-50 | 2020-03-05 | C162847 | 48780-1 | 9d75b9d0-4270-f424-e053-dadaa90a57ce | 446e1edb-8e98-4627-879d-9bd7f33da50f |
| 43547-383-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4270-f424-e053-dadaa90a57ce | 446e1edb-8e98-4627-879d-9bd7f33da50f |
| 43547-383-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4270-f424-e053-dadaa90a57ce | 446e1edb-8e98-4627-879d-9bd7f33da50f |
| 43547-383-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4270-f424-e053-dadaa90a57ce | 446e1edb-8e98-4627-879d-9bd7f33da50f |
| 43547-383-50 | 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 |
|---|---|---|---|---|---|
| 43547-383-10 | EA - Each | 43547-383 | f52359b5-7871-40ac-937b-f190c01168cb | 1 | 2016-11-08 |
| 43547-383-50 | EA - Each | 43547-383 | 6ee17d74-baa8-401c-821b-6f35562b96de | 1 | 2016-11-08 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310430 | gabapentin 100 MG Oral Capsule | PSN | 55b856aa-2835-4b96-9e52-08c375179b4a | 10 |
| 310431 | gabapentin 300 MG Oral Capsule | PSN | 55b856aa-2835-4b96-9e52-08c375179b4a | 10 |
| 310430 | gabapentin 100 MG Oral Capsule | SCD | 55b856aa-2835-4b96-9e52-08c375179b4a | 10 |
| 310431 | gabapentin 300 MG Oral Capsule | SCD | 55b856aa-2835-4b96-9e52-08c375179b4a | 10 |
| 310430 | gabapentin 100 MG Oral Capsule | PSN | 6aae39b6-be82-c9b5-e053-2991aa0a7d89 | 4 |
| 310430 | gabapentin 100 MG Oral Capsule | SCD | 6aae39b6-be82-c9b5-e053-2991aa0a7d89 | 4 |
| 310430 | gabapentin 100 MG Oral Capsule | PSN | 2e319a08-901d-40a9-e054-00144ff88e88 | 3 |
| 310431 | gabapentin 300 MG Oral Capsule | PSN | 2e319a08-901d-40a9-e054-00144ff88e88 | 3 |
| 310434 | gabapentin 800 MG Oral Tablet | PSN | 2e319a08-901d-40a9-e054-00144ff88e88 | 3 |
| 310430 | gabapentin 100 MG Oral Capsule | SCD | 2e319a08-901d-40a9-e054-00144ff88e88 | 3 |
| 310431 | gabapentin 300 MG Oral Capsule | SCD | 2e319a08-901d-40a9-e054-00144ff88e88 | 3 |
| 310434 | gabapentin 800 MG Oral Tablet | SCD | 2e319a08-901d-40a9-e054-00144ff88e88 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43547-383-03 | 43547038303 | 30 CAPSULE in 1 BOTTLE (43547-383-03) | 30 capsule | 2016-09-30 | 2022-07-10 | No | No | Current |
| 43547-383-10 | 43547038310 | 100 CAPSULE in 1 BOTTLE (43547-383-10) | 100 capsule | 2016-09-30 | 2022-07-10 | No | No | Current |
| 43547-383-11 | 43547038311 | 1000 CAPSULE in 1 BOTTLE (43547-383-11) | 1000 capsule | 2016-09-30 | 2022-07-10 | No | No | Current |
| 43547-383-50 | 43547038350 | 500 CAPSULE in 1 BOTTLE (43547-383-50) | 500 capsule | 2016-09-30 | 2022-07-10 | No | No | Current |