Gabapentin
- Product NDC
- 69097-811
- 11-digit product format
- 690970811
- Labeler code
- 69097
- Product ID
- 69097-811_69887d93-de9a-4397-a629-a0ce8e62c69a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA202764
- Marketing category
- ANDA
- Marketing start
- 2016-07-22
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gabapentin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GABAPENTIN | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 310433, 310434 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-811-02 | Gabapentin | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 69097-811-07 | Gabapentin | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 69097-811-12 | Gabapentin | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-811 | GABAPENTIN TABLET [CIPLA USA INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20230121_7c3ac86f-b8f7-42bf-942a-db854d946e54.zip |
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 |
|---|
| 69097-811-02 | 69097081102 | 30 TABLET in 1 BOTTLE (69097-811-02) | 30 tablet | 2016-07-22 | 0000-00-00 | No | No | Current |
| 69097-811-07 | 69097081107 | 100 TABLET in 1 BOTTLE (69097-811-07) | 100 tablet | 2016-07-22 | 0000-00-00 | No | No | Current |
| 69097-811-12 | 69097081112 | 500 TABLET in 1 BOTTLE (69097-811-12) | 500 tablet | 2016-07-22 | 0000-00-00 | No | No | Current |