Gabapentin
- Product NDC
- 69367-135
- 11-digit product format
- 693670135
- Labeler code
- 69367
- Product ID
- 69367-135_1647af99-e383-471a-a4fd-15dad8bfc4e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA205101
- Marketing category
- ANDA
- Marketing start
- 2016-04-11
- 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
- 2023-12-31
- 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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69367-135-04 | EA - Each | 69367-135 | 335b10f0-e6be-4300-993f-f5a36b9d5177 | 1 | 2018-06-11 |
| 69367-135-06 | EA - Each | 69367-135 | f32d02d9-253c-41c2-bdcf-74726c7c166f | 1 | 2016-07-19 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310433 | gabapentin 600 MG Oral Tablet | PSN | b67b7865-df64-429a-9550-5333b9c713ea | 4 |
| 310434 | gabapentin 800 MG Oral Tablet | PSN | b67b7865-df64-429a-9550-5333b9c713ea | 4 |
| 310433 | gabapentin 600 MG Oral Tablet | SCD | b67b7865-df64-429a-9550-5333b9c713ea | 4 |
| 310434 | gabapentin 800 MG Oral Tablet | SCD | b67b7865-df64-429a-9550-5333b9c713ea | 4 |
| 310434 | gabapentin 800 MG Oral Tablet | PSN | f47d512a-5aa1-4b53-93b6-5c4733634ae0 | 2 |
| 310434 | gabapentin 800 MG Oral Tablet | SCD | f47d512a-5aa1-4b53-93b6-5c4733634ae0 | 2 |
| 310434 | gabapentin 800 MG Oral Tablet | PSN | 08decd82-6f81-453c-b129-ecef80d4875c | 1 |
| 310434 | gabapentin 800 MG Oral Tablet | PSN | 35004f84-90ae-45f0-a2ba-653dec507229 | 1 |
| 310434 | gabapentin 800 MG Oral Tablet | SCD | 08decd82-6f81-453c-b129-ecef80d4875c | 1 |
| 310434 | gabapentin 800 MG Oral Tablet | SCD | 35004f84-90ae-45f0-a2ba-653dec507229 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69367-135-03 | 69367013503 | 90 TABLET in 1 BOTTLE (69367-135-03) | 90 tablet | 2016-04-11 | 0000-00-00 | No | No | Current |
| 69367-135-04 | 69367013504 | 100 TABLET in 1 BOTTLE (69367-135-04) | 100 tablet | 2018-04-30 | 0000-00-00 | No | No | Current |
| 69367-135-06 | 69367013506 | 500 TABLET in 1 BOTTLE (69367-135-06) | 500 tablet | 2016-04-11 | 0000-00-00 | No | No | Current |