Loxapine
- Product NDC
- 0527-1396
- 11-digit product format
- 005271396
- Labeler code
- 0527
- Product ID
- 0527-1396_d237714b-55f8-4a6e-9297-c10d41ab3cd2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loxapine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA090695
- Marketing category
- ANDA
- Marketing start
- 2011-09-26
- Substance
- LOXAPINE SUCCINATE
- Active strength
- 25 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loxapine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOXAPINE SUCCINATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X59SG0MRYU |
| Rxcui | 311385, 311386, 314075, 314078 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0527-1396-01 | Loxapine | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 20 |
| 0527-1396-10 | Loxapine | 1000 in 1 BOTTLE, PLASTIC | CAPSULE | 1000 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-1396 | LOXAPINE CAPSULE [LANNETT COMPANY, INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20241120_509bad3c-b563-4042-b270-d28bde19f224.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 |
|---|
| 0527-1396-01 | 00527139601 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0527-1396-01) | 100 capsule | 2011-09-26 | 0000-00-00 | No | No | Current |
| 0527-1396-10 | 00527139610 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0527-1396-10) | 1000 capsule | 2011-09-26 | 0000-00-00 | No | No | Current |