Ciclopirox Olamine
- Product NDC
- 51672-1318
- 11-digit product format
- 516721318
- Labeler code
- 51672
- Product ID
- 51672-1318_4882ff99-b917-693b-e063-6394a90a4476
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ciclopirox olamine
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA076790
- Marketing category
- ANDA
- Marketing start
- 2005-04-12
- Substance
- CICLOPIROX OLAMINE
- Active strength
- 7.7 mg/g
- Pharmacologic classes
- Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ciclopirox Olamine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CICLOPIROX OLAMINE | 7.7 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 50MD4SB4AP |
| Rxcui | 309289 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-1318-1 | Ciclopirox Olamine | 1 in 1 CARTON | CREAM | 1 | | 9 |
| 51672-1318-1 | Ciclopirox Olamine | 15 g in 1 TUBE | CREAM | 15 | | 9 |
| 51672-1318-2 | Ciclopirox Olamine | 30 g in 1 TUBE | CREAM | 30 | | 9 |
| 51672-1318-2 | Ciclopirox Olamine | 1 in 1 CARTON | CREAM | 1 | | 9 |
| 51672-1318-8 | Ciclopirox Olamine | 90 g in 1 TUBE | CREAM | 90 | | 9 |
| 51672-1318-8 | Ciclopirox Olamine | 1 in 1 CARTON | CREAM | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ciclopirox olamine | ACTIVE INGREDIENT | 50MD4SB4AP | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| ciclopirox olamine | ACTIVE INGREDIENT | 50MD4SB4AP | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| Ciclopirox | ACTIVE MOIETY | 19W019ZDRJ | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| Ciclopirox | ACTIVE MOIETY | 19W019ZDRJ | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| Coco Diethanolamide | INACTIVE INGREDIENT | 92005F972D | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| Coco Diethanolamide | INACTIVE INGREDIENT | 92005F972D | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| lactic acid | INACTIVE INGREDIENT | 33X04XA5AT | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| lactic acid | INACTIVE INGREDIENT | 33X04XA5AT | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| mineral oil | INACTIVE INGREDIENT | T5L8T28FGP | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| mineral oil | INACTIVE INGREDIENT | T5L8T28FGP | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| myristyl alcohol | INACTIVE INGREDIENT | V42034O9PU | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| myristyl alcohol | INACTIVE INGREDIENT | V42034O9PU | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| octyldodecanol | INACTIVE INGREDIENT | 461N1O614Y | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| octyldodecanol | INACTIVE INGREDIENT | 461N1O614Y | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | CICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-1318 | CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20241222_7fa4032e-a819-4574-b484-c57aaf1c5b01.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 |
|---|
| 51672-1318-1 | 51672131801 | 1 TUBE in 1 CARTON (51672-1318-1) / 15 g in 1 TUBE | 1 tube | 2005-04-12 | 0000-00-00 | No | No | Current |
| 51672-1318-2 | 51672131802 | 1 TUBE in 1 CARTON (51672-1318-2) / 30 g in 1 TUBE | 1 tube | 2005-04-12 | 0000-00-00 | No | No | Current |
| 51672-1318-8 | 51672131808 | 1 TUBE in 1 CARTON (51672-1318-8) / 90 g in 1 TUBE | 1 tube | 2005-04-12 | 0000-00-00 | No | No | Current |