Gabapentin
- Product NDC
- 43547-333
- 11-digit product format
- 435470333
- Labeler code
- 43547
- Product ID
- 43547-333_a5acb151-2034-4baf-bbfe-1c056c1870a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GABAPENTIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Solco Healthcare U.S., LLC
- Application
- ANDA203244
- Marketing category
- ANDA
- Marketing start
- 2014-01-11
- Marketing end
- 2020-08-15
- 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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43547-333-10 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-6f5b-f424-e053-dadaa90a57ce | d45f499b-8612-479e-8dd2-4fe28b1f5f9c |
| 43547-333-50 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-6f5b-f424-e053-dadaa90a57ce | d45f499b-8612-479e-8dd2-4fe28b1f5f9c |
| 43547-333-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6f5b-f424-e053-dadaa90a57ce | d45f499b-8612-479e-8dd2-4fe28b1f5f9c |
| 43547-333-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6f5b-f424-e053-dadaa90a57ce | d45f499b-8612-479e-8dd2-4fe28b1f5f9c |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-333-10 | EA - Each | 43547-333 | 71ee9065-5af6-4258-ba42-11366cadca18 | 1 | 2014-12-01 |
| 43547-333-50 | EA - Each | 43547-333 | b66d7473-1923-47a4-a6b0-6ca0edda37a1 | 1 | 2014-12-01 |