Cevimeline Hydrochloride
- Product NDC
- 71335-2264
- 11-digit product format
- 713352264
- Labeler code
- 71335
- Product ID
- 71335-2264_ea0ecfd4-85b2-47c8-8113-755d28555607
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cevimeline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091591
- Marketing category
- ANDA
- Marketing start
- 2013-07-08
- 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 |
|---|
| 71335-2264-1 | Cevimeline Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 101 |
| 71335-2264-2 | Cevimeline Hydrochloride | 60 in 1 BOTTLE | CAPSULE | 60 | | 101 |
| 71335-2264-3 | Cevimeline Hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2264 | CEVIMELINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] | 101 | Current NDC, 3 package rows | 20241022_fe30c870-a060-4a5b-ae61-6a9933854419.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2264-1 | 71335226401 | 30 CAPSULE in 1 BOTTLE (71335-2264-1) | 30 capsule | 2023-10-27 | No | No | Historical |
| 71335-2264-2 | 71335226402 | 60 CAPSULE in 1 BOTTLE (71335-2264-2) | 60 capsule | 2023-10-27 | No | No | Historical |
| 71335-2264-3 | 71335226403 | 90 CAPSULE in 1 BOTTLE (71335-2264-3) | 90 capsule | 2023-10-27 | No | No | Historical |