Gabapentin
- Product NDC
- 35356-708
- 11-digit product format
- 353560708
- Labeler code
- 35356
- Product ID
- 35356-708_2cebc04c-8c24-45dc-b3de-80e27b6dc144
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
- Application
- ANDA078428
- Marketing category
- ANDA
- Marketing start
- 2009-11-24
- Marketing end
- 0000-00-00
- Substance
- GABAPENTIN
- Active strength
- 300 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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 35356-708-01 | 2021-10-19 | C162847 | 48780-1 | ba0f9c33-5a63-a910-e053-dadaa90a0b85 | 91bfbccd-2cd2-4ff7-9b3e-70dbdded1e2b |
| 35356-708-30 | 2021-10-19 | C162847 | 48780-1 | ba0f9c33-5a63-a910-e053-dadaa90a0b85 | 91bfbccd-2cd2-4ff7-9b3e-70dbdded1e2b |
| 35356-708-60 | 2021-10-19 | C162847 | 48780-1 | ba0f9c33-5a63-a910-e053-dadaa90a0b85 | 91bfbccd-2cd2-4ff7-9b3e-70dbdded1e2b |
| 35356-708-90 | 2021-10-19 | C162847 | 48780-1 | ba0f9c33-5a63-a910-e053-dadaa90a0b85 | 91bfbccd-2cd2-4ff7-9b3e-70dbdded1e2b |
| 35356-708-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5a63-a910-e053-dadaa90a0b85 | 91bfbccd-2cd2-4ff7-9b3e-70dbdded1e2b |
| 35356-708-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5a63-a910-e053-dadaa90a0b85 | 91bfbccd-2cd2-4ff7-9b3e-70dbdded1e2b |
| 35356-708-60 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5a63-a910-e053-dadaa90a0b85 | 91bfbccd-2cd2-4ff7-9b3e-70dbdded1e2b |
| 35356-708-90 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5a63-a910-e053-dadaa90a0b85 | 91bfbccd-2cd2-4ff7-9b3e-70dbdded1e2b |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 35356-708-01 | EA - Each | 35356-708 | 7b6a61c4-82b0-4d9c-8ee4-f0224f974df8 | 1 | 2012-07-24 |
| 35356-708-30 | EA - Each | 35356-708 | 41cb77cb-2952-42fb-8cb0-9a1379199c54 | 1 | 2012-07-24 |
| 35356-708-60 | EA - Each | 35356-708 | 604089b7-8cd2-4b74-b446-e1318949e740 | 1 | 2012-07-24 |
| 35356-708-90 | EA - Each | 35356-708 | ff8c27ab-5ba2-4c9c-ac15-6679bf38a803 | 1 | 2012-07-24 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 35356-708-01 | 35356070801 | 120 CAPSULE in 1 BOTTLE (35356-708-01) | 120 capsule | 2009-11-24 | 0000-00-00 | No | No | Current |
| 35356-708-30 | 35356070830 | 30 CAPSULE in 1 BOTTLE (35356-708-30) | 30 capsule | 2009-11-24 | 0000-00-00 | No | No | Current |
| 35356-708-60 | 35356070860 | 60 CAPSULE in 1 BOTTLE (35356-708-60) | 60 capsule | 2009-11-24 | 0000-00-00 | No | No | Current |