Cevimeline
- Product NDC
- 63304-479
- 11-digit product format
- 633040479
- Labeler code
- 63304
- Product ID
- 63304-479_558c3230-3788-4ef0-a5b5-3c06870317a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cevimeline
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- NDA020989
- Marketing category
- NDA
- Marketing start
- 2016-03-10
- Marketing end
- 2027-04-30
- Substance
- CEVIMELINE HYDROCHLORIDE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cevimeline
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 |
|---|
| 63304-479-01 | Cevimeline | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-479 | CEVIMELINE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 10 | Current NDC, Legacy NDC, 1 package rows | 20220721_773a19e8-4c3e-4414-99a6-aea98c9790ee.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 |
|---|
| 63304-479-01 | 63304047901 | 100 CAPSULE in 1 BOTTLE (63304-479-01) | 100 capsule | 2016-03-10 | 2027-04-30 | No | No | Current |