cevimeline hydrochloride
- Product NDC
- 0713-0937
- 11-digit product format
- 007130937
- Labeler code
- 0713
- Product ID
- 0713-0937_f183f958-57f5-ea10-e053-2995a90a5ead
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cevimeline hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- NDA020989
- Marketing category
- NDA
- Marketing start
- 2023-01-03
- Substance
- CEVIMELINE HYDROCHLORIDE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- cevimeline hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CEVIMELINE HYDROCHLORIDE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P81Q6V85NP |
| Rxcui | 309140 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0937-01 | cevimeline hydrochloride | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0937 | CEVIMELINE HYDROCHLORIDE CAPSULE [COSETTE PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20230106_efc2bb24-4dda-4781-bef5-fcd9abf082dd.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 |
|---|
| 0713-0937-01 | 00713093701 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0937-01) | 100 capsule | 2023-01-03 | 0000-00-00 | No | No | Current |