Cevimeline Hydrochloride
- Product NDC
- 70771-1982
- 11-digit product format
- 707711982
- Labeler code
- 70771
- Product ID
- 70771-1982_7e885fcf-536e-4d43-94c8-2941e9e9a7a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cevimeline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA220267
- Marketing category
- ANDA
- Marketing start
- 2026-04-15
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A220267-001 | CEVIMELINE HYDROCHLORIDE | CEVIMELINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AB | | 2026-03-11 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A220267-001 | AB |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cevimeline Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 70771-1982-1 | Cevimeline Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1982-1 | 70771198201 | 100 CAPSULE in 1 BOTTLE (70771-1982-1) | 100 capsule | 2026-04-15 | No | No | Current |