Clotrimazole
- Product NDC
- 0054-4146
- 11-digit product format
- 000544146
- Labeler code
- 0054
- Product ID
- 0054-4146_3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clotrimazole
- Dosage form
- LOZENGE
- Route
- ORAL; TOPICAL
- Labeler
- Hikma Pharmacuticals USA USA Inc.
- Application
- ANDA076387
- Marketing category
- ANDA
- Marketing start
- 2004-07-29
- Substance
- CLOTRIMAZOLE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clotrimazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOTRIMAZOLE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G07GZ97H65 |
| Rxcui | 309371 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-4146-22 | Clotrimazole | 70 in 1 BOTTLE, PLASTIC | LOZENGE | 70 | | 14 |
| 0054-4146-23 | Clotrimazole | 140 in 1 BOTTLE, PLASTIC | LOZENGE | 140 | | 14 |
| 0054-4146-22 | Clotrimazole | 70 in 1 BOTTLE, PLASTIC | LOZENGE | 70 | | 1 |
| 0054-4146-23 | Clotrimazole | 140 in 1 BOTTLE, PLASTIC | LOZENGE | 140 | | 1 |
| 0054-8146-22 | Clotrimazole | 70 in 1 BLISTER PACK | LOZENGE | 70 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLOTRIMAZOLE | ACTIVE INGREDIENT | G07GZ97H65 | CLOTRIMAZOLE LOZENGE [ROXANE LABORATORIES, INC] | 9 | |
| CLOTRIMAZOLE | ACTIVE MOIETY | G07GZ97H65 | CLOTRIMAZOLE LOZENGE [ROXANE LABORATORIES, INC] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOTRIMAZOLE LOZENGE [ROXANE LABORATORIES, INC] | 9 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CLOTRIMAZOLE LOZENGE [ROXANE LABORATORIES, INC] | 9 | |
| DEXTRATES | INACTIVE INGREDIENT | G263MI44RU | CLOTRIMAZOLE LOZENGE [ROXANE LABORATORIES, INC] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CLOTRIMAZOLE LOZENGE [ROXANE LABORATORIES, INC] | 9 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CLOTRIMAZOLE LOZENGE [ROXANE LABORATORIES, INC] | 9 | |
| clotrimazole | ACTIVE INGREDIENT | G07GZ97H65 | CLOTRIMAZOLE LOZENGE [ROXANE] | 1 | |
| clotrimazole | ACTIVE MOIETY | G07GZ97H65 | CLOTRIMAZOLE LOZENGE [ROXANE] | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | | CLOTRIMAZOLE LOZENGE [ROXANE] | 1 | |
| dextrates | INACTIVE INGREDIENT | | CLOTRIMAZOLE LOZENGE [ROXANE] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | CLOTRIMAZOLE LOZENGE [ROXANE] | 1 | |
| microcrystalline cellulose | INACTIVE INGREDIENT | OP1R32D61U | CLOTRIMAZOLE LOZENGE [ROXANE] | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | CLOTRIMAZOLE LOZENGE [ROXANE] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-4146 | CLOTRIMAZOLE LOZENGE [HIKMA PHARMACUTICALS USA USA INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240515_0bc4b876-ddee-4f03-b44f-544348739a26.zip |
| 0054-4146 | CLOTRIMAZOLE LOZENGE [ROXANE] | 1 | Current NDC, Legacy NDC, 3 package rows | 20081202_A0829286-E9FC-442C-82D1-8268E1110109.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 |
|---|
| 0054-4146-22 | 00054414622 | 70 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-22) | 70 lozenge | 2004-07-29 | 0000-00-00 | No | No | Current |
| 0054-4146-23 | 00054414623 | 140 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-23) | 140 lozenge | 2004-07-29 | 0000-00-00 | No | No | Current |
| 0054-8146-22 | 00054814622 | 70 in 1 BLISTER PACK | | | | | | Historical |