ciclopirox
- Product NDC
- 68462-455
- 11-digit product format
- 684620455
- Labeler code
- 68462
- Product ID
- 68462-455_941ab9d0-0c94-48f9-a8d2-8f164b050a6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ciclopirox
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA091595
- Marketing category
- ANDA
- Marketing start
- 2012-02-29
- Substance
- CICLOPIROX
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CICLOPIROX | 7.7 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 19W019ZDRJ |
| Rxcui | 313941 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-455-35 | ciclopirox | 30 g in 1 TUBE | GEL | 30 | | 6 |
| 68462-455-47 | ciclopirox | 45 g in 1 TUBE | GEL | 45 | | 6 |
| 68462-455-94 | ciclopirox | 100 g in 1 TUBE | GEL | 100 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CICLOPIROX | ACTIVE INGREDIENT | 19W019ZDRJ | CICLOPIROX GEL [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| CICLOPIROX | ACTIVE MOIETY | 19W019ZDRJ | CICLOPIROX GEL [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | CICLOPIROX GEL [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | CICLOPIROX GEL [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | CICLOPIROX GEL [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | CICLOPIROX GEL [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CICLOPIROX GEL [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CICLOPIROX GEL [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-455 | CICLOPIROX GEL [GLENMARK PHARMACEUTICALS INC., USA] | 5 | Current NDC, Legacy NDC, 3 package rows | 20170608_3c22416e-4293-4ba5-a983-137cbc6022db.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 |
|---|
| 68462-455-35 | 68462045535 | 30 g in 1 TUBE (68462-455-35) | 30 g | 2012-02-29 | 0000-00-00 | No | No | Current |
| 68462-455-47 | 68462045547 | 45 g in 1 TUBE (68462-455-47) | 45 g | 2012-02-29 | 0000-00-00 | No | No | Current |
| 68462-455-94 | 68462045594 | 100 g in 1 TUBE (68462-455-94) | 100 g | 2012-02-29 | 0000-00-00 | No | No | Current |