Clotrimazole
- Product NDC
- 0574-0107
- 11-digit product format
- 005740107
- Labeler code
- 0574
- Product ID
- 0574-0107_c3d8e3ce-0429-4979-a91d-58dd19bbe996
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clotrimazole
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Padagis US LLC
- Application
- ANDA076763
- Marketing category
- ANDA
- Marketing start
- 2005-12-01
- 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 |
|---|
| 0574-0107-14 | Clotrimazole | 140 in 1 BOTTLE, PLASTIC | LOZENGE | 140 | | 6 |
| 0574-0107-70 | Clotrimazole | 70 in 1 BOTTLE, PLASTIC | LOZENGE | 70 | | 6 |
| 0574-0107-77 | Clotrimazole | 1 in 1 PACKET | LOZENGE | 1 | | 6 |
| 0574-0107-77 | Clotrimazole | 70 in 1 BOX | LOZENGE | 70 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLOTRIMAZOLE | ACTIVE INGREDIENT | G07GZ97H65 | CLOTRIMAZOLE LOZENGE [PADDOCK LABORATORIES, LLC] | 3 | |
| CLOTRIMAZOLE | ACTIVE MOIETY | G07GZ97H65 | CLOTRIMAZOLE LOZENGE [PADDOCK LABORATORIES, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOTRIMAZOLE LOZENGE [PADDOCK LABORATORIES, LLC] | 3 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | CLOTRIMAZOLE LOZENGE [PADDOCK LABORATORIES, LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CLOTRIMAZOLE LOZENGE [PADDOCK LABORATORIES, LLC] | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CLOTRIMAZOLE LOZENGE [PADDOCK LABORATORIES, LLC] | 3 | |
| CLOTRIMAZOLE | ACTIVE INGREDIENT | G07GZ97H65 | CLOTRIMAZOLE LOZENGE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| CLOTRIMAZOLE | ACTIVE MOIETY | G07GZ97H65 | CLOTRIMAZOLE LOZENGE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOTRIMAZOLE LOZENGE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | CLOTRIMAZOLE LOZENGE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CLOTRIMAZOLE LOZENGE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CLOTRIMAZOLE LOZENGE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0574-0107 | CLOTRIMAZOLE LOZENGE [PADAGIS US LLC] | 6 | Current NDC, Legacy NDC, 4 package rows | 20231202_3f57ef51-8202-4d0b-95a8-d2df468b8d9a.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 |
|---|
| 0574-0107-14 | 00574010714 | 140 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-14) | 140 lozenge | 2005-12-01 | 0000-00-00 | No | No | Current |
| 0574-0107-70 | 00574010770 | 70 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-70) | 70 lozenge | 2005-12-01 | 0000-00-00 | No | No | Current |
| 0574-0107-77 | 00574010777 | 70 PACKET in 1 BOX (0574-0107-77) / 1 LOZENGE in 1 PACKET | 70 packet | 2005-12-01 | 0000-00-00 | No | No | Current |