Ciclopirox Olamine
- Product NDC
- 68462-297
- 11-digit product format
- 684620297
- Labeler code
- 68462
- Product ID
- 68462-297_740c1d91-06c1-4508-9e94-e5308bec9be3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciclopirox Olamine
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA090273
- Marketing category
- ANDA
- Marketing start
- 2009-11-13
- 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 |
|---|
| 68462-297-17 | Ciclopirox Olamine | 15 g in 1 CARTON | CREAM | 15 | | 12 |
| 68462-297-35 | Ciclopirox Olamine | 30 g in 1 CARTON | CREAM | 30 | | 12 |
| 68462-297-92 | Ciclopirox Olamine | 90 g in 1 CARTON | CREAM | 90 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CICLOPIROX OLAMINE | ACTIVE INGREDIENT | 50MD4SB4AP | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| CICLOPIROX | ACTIVE MOIETY | 19W019ZDRJ | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| MYRISTYL ALCOHOL | INACTIVE INGREDIENT | V42034O9PU | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| CICLOPIROX OLAMINE | ACTIVE INGREDIENT | 50MD4SB4AP | CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] | 3 | |
| CICLOPIROX | ACTIVE MOIETY | 19W019ZDRJ | CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] | 3 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] | 3 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] | 3 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] | 3 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] | 3 | |
| MYRISTYL ALCOHOL | INACTIVE INGREDIENT | V42034O9PU | CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] | 3 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] | 3 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] | 3 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] | 3 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CICLOPIROX OLAMINE CREAM [DISPENSING SOLUTIONS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-297 | CICLOPIROX OLAMINE CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 11 | Current NDC, Legacy NDC, 3 package rows | 20240104_7385cf42-9f80-4542-8e0f-a0228aa9b43a.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 |
|---|
| 68462-297-17 | 68462029717 | 15 g in 1 CARTON (68462-297-17) | 15 g | 2009-11-13 | 0000-00-00 | No | No | Current |
| 68462-297-35 | 68462029735 | 30 g in 1 CARTON (68462-297-35) | 30 g | 2009-11-13 | 0000-00-00 | No | No | Current |
| 68462-297-92 | 68462029792 | 90 g in 1 CARTON (68462-297-92) | 90 g | 2009-11-13 | 0000-00-00 | No | No | Current |