Gabapentin
- Product NDC
- 44523-120
- 11-digit product format
- 445230120
- Labeler code
- 44523
- Product ID
- 44523-120_462c7cf4-92a8-cf81-e063-6294a90a43c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gabapentin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- BioComp Pharma, Inc.
- Application
- ANDA078974
- Marketing category
- ANDA
- Marketing start
- 2023-11-30
- Substance
- GABAPENTIN
- Active strength
- 250 mg/5mL
- Pharmacologic classes
- 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 | 250 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6CW7F3G59X |
| Rxcui | 283523 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 44523-120-16 | Gabapentin | 470 mL in 1 BOTTLE | SOLUTION | 470 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44523-120 | GABAPENTIN SOLUTION [BIOCOMP PHARMA, INC.] | 5 | Current NDC, 1 package rows | 20240622_0b3a4009-42f3-c84f-e063-6294a90a8068.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 44523-120-16 | 44523012016 | 470 mL in 1 BOTTLE (44523-120-16) | 470 ml | 2023-11-30 | No | No | Current |