cevimeline hydrochloride
- Product NDC
- 40032-999
- 11-digit product format
- 400320999
- Labeler code
- 40032
- Product ID
- 40032-999_c42fae45-bbcf-40b6-911d-ebe3893f10ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cevimeline hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Novel Laboratories, Inc.
- Application
- ANDA204746
- Marketing category
- ANDA
- Marketing start
- 2016-12-30
- 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 |
|---|
| 40032-999-01 | cevimeline hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 40032-999-03 | cevimeline hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 40032-999-05 | cevimeline hydrochloride | 500 in 1 BOTTLE | CAPSULE | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 40032-999 | CEVIMELINE HYDROCHLORIDE CAPSULE [NOVEL LABORATORIES, INC.] | 1 | Current NDC, Legacy NDC, 3 package rows | 20171207_d7432a48-1142-431e-997f-8419dc724824.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 |
|---|
| 40032-999-01 | 40032099901 | 100 CAPSULE in 1 BOTTLE (40032-999-01) | 100 capsule | 2016-12-30 | 0000-00-00 | No | No | Current |
| 40032-999-03 | 40032099903 | 30 CAPSULE in 1 BOTTLE (40032-999-03) | 30 capsule | 2016-12-30 | 0000-00-00 | No | No | Current |
| 40032-999-05 | 40032099905 | 500 CAPSULE in 1 BOTTLE (40032-999-05) | 500 capsule | 2016-12-30 | 0000-00-00 | No | No | Current |