CEVIMELINE
- Product NDC
- 69452-316
- 11-digit product format
- 694520316
- Labeler code
- 69452
- Product ID
- 69452-316_10e26216-a6d9-ab89-e063-6294a90a298c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CEVIMELINE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bionpharma Inc
- Application
- ANDA218290
- Marketing category
- ANDA
- Marketing start
- 2024-01-17
- 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
- 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 |
|---|
| 69452-316-20 | CEVIMELINE | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-316 | CEVIMELINE (CEVIMELINE HYDROCHLORIDE) CAPSULE [BIONPHARMA INC] | 2 | Current NDC, 1 package rows | 20240217_0f15cb50-5917-c928-e063-6294a90ab284.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 |
|---|
| 69452-316-20 | 69452031620 | 100 CAPSULE in 1 BOTTLE (69452-316-20) | 100 capsule | 2024-01-17 | No | No | Current |