Cevimeline Hydrochloride
- Product NDC
- 72162-2563
- 11-digit product format
- 721622563
- Labeler code
- 72162
- Product ID
- 72162-2563_fb360aef-a237-424f-95a0-f39d33113bd7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cevimeline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA215056
- Marketing category
- ANDA
- Marketing start
- 2023-04-18
- 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 |
|---|
| 72162-2563-1 | Cevimeline Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 100 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2563-1 | 72162256301 | 100 CAPSULE in 1 BOTTLE (72162-2563-1) | 100 capsule | 2025-11-04 | No | No | Current |