CLEMASTINE FUMARATE
- Product NDC
- 62135-713
- 11-digit product format
- 621350713
- Labeler code
- 62135
- Product ID
- 62135-713_ffe63870-181f-e007-e053-6294a90a074e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CLEMASTINE FUMARATE
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA074884
- Marketing category
- ANDA
- Marketing start
- 1997-12-17
- Substance
- CLEMASTINE FUMARATE
- Active strength
- .67 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CLEMASTINE FUMARATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLEMASTINE FUMARATE | .67 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19259EGQ3D |
| Rxcui | 857430 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-713-41 | CLEMASTINE FUMARATE | 120 mL in 1 BOTTLE | SYRUP | 120 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-713 | CLEMASTINE FUMARATE SYRUP [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20230708_6663f1b0-5353-401f-b9d3-d9f69ad08fbf.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 |
|---|
| 62135-713-41 | 62135071341 | 120 mL in 1 BOTTLE (62135-713-41) | 120 ml | 2023-07-07 | No | No | Historical |