Gabapentin
- Product NDC
- 70518-2970
- 11-digit product format
- 705182970
- Labeler code
- 70518
- Product ID
- 70518-2970_4e5391f3-de17-7644-e063-6294a90ab56b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA204989
- Marketing category
- ANDA
- Marketing start
- 2020-12-16
- Substance
- GABAPENTIN
- Active strength
- 300 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gabapentin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GABAPENTIN | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310431 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70518-2970-0 | 2024-03-09 | C162847 | 48780-1 | d6a99b39-6756-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 |
| 70518-2970-0 | 2024-03-09 | C162847 | 48780-1 | d6a99b39-6756-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 |
| 70518-2970-0 | 2024-01-30 | C162847 | 48780-1 | d6a99b39-6756-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 |
| 70518-2970-0 | 2024-01-30 | C162847 | 48780-1 | d6a99b39-6756-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 |
| 70518-2970-0 | 2022-02-10 | C162847 | 48780-1 | d6a99b39-6756-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 |
| 70518-2970-0 | 2022-02-10 | C162847 | 48780-1 | d6a99b39-6756-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 |
| 70518-2970-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6756-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 |
| 70518-2970-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6756-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN capsules, for oral use GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-2970-0 | Gabapentin | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 10 |
| 70518-2970-1 | Gabapentin | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 10 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2970-0 | 70518297000 | 30 CAPSULE in 1 BOTTLE, PLASTIC (70518-2970-0) | 30 capsule | 2020-12-16 | 0000-00-00 | No | No | Current |
| 70518-2970-1 | 70518297001 | 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-2970-1) | 90 capsule | 2024-01-19 | | No | No | Current |