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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| P81Q6V85NP | CEVIMELINE HYDROCHLORIDE | 153504-70-2 | CEVIMELINE HYDROCHLORIDE |
| K9V0CDQ56E | CEVIMELINE | 107233-08-9 | Cevimeline |
Packages
| 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 | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Cevimeline | Sun Pharmaceutical Industries, Inc. | 2022-07-15 | HUMAN PRESCRIPTION DRUG LABEL | 10 |