CLEMSZA
- Product NDC
- 71085-081
- 11-digit product format
- 710850081
- Labeler code
- 71085
- Product ID
- 71085-081_3b2a232e-e840-b8e1-e063-6394a90ae51d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clemastine Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- IPG Pharmaceuticals, Inc.
- Application
- ANDA073283
- Marketing category
- ANDA
- Marketing start
- 2025-08-01
- Substance
- CLEMASTINE FUMARATE
- Active strength
- 2.68 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
- CLEMSZA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLEMASTINE FUMARATE | 2.68 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19259EGQ3D |
| Rxcui | 857461, 2720338 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71085-081-30 | CLEMSZA | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71085-081-30 | 71085008130 | 30 TABLET in 1 BOTTLE (71085-081-30) | 30 tablet | 2025-08-01 | No | No | Historical |