Cevimeline Hydrochloride
- Product NDC
- 0054-0334
- 11-digit product format
- 000540334
- Labeler code
- 0054
- Product ID
- 0054-0334_3cca3720-dca8-40cf-8de7-8f3444125ece
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cevimeline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- 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 |
|---|
| 0054-0334-25 | Cevimeline Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CEVIMELINE HYDROCHLORIDE | ACTIVE INGREDIENT | P81Q6V85NP | CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] | 1 | |
| CEVIMELINE | ACTIVE MOIETY | K9V0CDQ56E | CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0334 | CEVIMELINE HYDROCHLORIDE CAPSULE [HIKMA PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240913_1167360c-7e0f-4619-9d1a-ad4ee56cab71.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 |
|---|
| 0054-0334-25 | 00054033425 | 100 CAPSULE in 1 BOTTLE (0054-0334-25) | 100 capsule | 2013-07-08 | 0000-00-00 | No | No | Current |