Ciclopirox
- Product NDC
- 50383-419
- 11-digit product format
- 503830419
- Labeler code
- 50383
- Product ID
- 50383-419_32cc9876-cc79-49c7-bbe9-e3b823411ef4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciclopirox
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Akorn
- Application
- ANDA078270
- Marketing category
- ANDA
- Marketing start
- 2007-09-18
- Marketing end
- 0000-00-00
- Substance
- CICLOPIROX
- Active strength
- 71 mg/mL
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| d24c6245-86b5-4444-bc75-c1ac73ab3016 | Product name | 1 | 20180612 |
| c7015f08-288e-4cfa-93b5-f4959a4814ae | Product name | 1 | 20150324 |
| 3f974526-143f-9d19-ee0c-98eeee0cdc3f | Product name | 1 | 20140508 |
| 5c035cac-559a-7171-c5cb-f0bd0d0fbc86 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50383-419-03 | 2024-01-30 | C162847 | 48780-1 | d6a99b39-6359-a426-e053-dadaa90af4c2 | Ciclopirox Topical Solution, 8% (Nail Lacquer) |
| 50383-419-06 | 2024-01-30 | C162847 | 48780-1 | d6a99b39-6359-a426-e053-dadaa90af4c2 | Ciclopirox Topical Solution, 8% (Nail Lacquer) |
| 50383-419-03 | 2022-02-01 | C162847 | 48780-1 | d6a99b39-6359-a426-e053-dadaa90af4c2 | Ciclopirox Topical Solution, 8% (Nail Lacquer) |
| 50383-419-06 | 2022-02-01 | C162847 | 48780-1 | d6a99b39-6359-a426-e053-dadaa90af4c2 | Ciclopirox Topical Solution, 8% (Nail Lacquer) |
| 50383-419-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6359-a426-e053-dadaa90af4c2 | Ciclopirox Topical Solution, 8% (Nail Lacquer) |
| 50383-419-06 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6359-a426-e053-dadaa90af4c2 | Ciclopirox Topical Solution, 8% (Nail Lacquer) |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50383-419-06 | ML - Milliliter | 50383-419 | 7b8bc6ba-fb26-4b7d-90fc-456d5ec0060e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CICLOPIROX | ACTIVE INGREDIENT | 19W019ZDRJ | CICLOPIROX SOLUTION [HI-TECH PHARMACAL CO., INC.] | 2 | |
| CICLOPIROX | ACTIVE MOIETY | 19W019ZDRJ | CICLOPIROX SOLUTION [HI-TECH PHARMACAL CO., INC.] | 2 | |
| ETHYL ACETATE | INACTIVE INGREDIENT | 76845O8NMZ | CICLOPIROX SOLUTION [HI-TECH PHARMACAL CO., INC.] | 2 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | CICLOPIROX SOLUTION [HI-TECH PHARMACAL CO., INC.] | 2 | |
| MALEIC ACID | INACTIVE INGREDIENT | 91XW058U2C | CICLOPIROX SOLUTION [HI-TECH PHARMACAL CO., INC.] | 2 | |
| CICLOPIROX | ACTIVE INGREDIENT | 19W019ZDRJ | CICLOPIROX SOLUTION [REBEL DISTRIBUTORS CORP.] | 1 | |
| CICLOPIROX | ACTIVE MOIETY | 19W019ZDRJ | CICLOPIROX SOLUTION [REBEL DISTRIBUTORS CORP.] | 1 | |
| ETHYL ACETATE | INACTIVE INGREDIENT | 76845O8NMZ | CICLOPIROX SOLUTION [REBEL DISTRIBUTORS CORP.] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | CICLOPIROX SOLUTION [REBEL DISTRIBUTORS CORP.] | 1 | |
| MALEIC ACID | INACTIVE INGREDIENT | 91XW058U2C | CICLOPIROX SOLUTION [REBEL DISTRIBUTORS CORP.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309291 | ciclopirox 8 % Topical Solution | PSN | ee775b56-0575-41e4-a948-c92a0bcd69b6 | 1 |
| 309291 | ciclopirox 80 MG/ML Topical Solution | SCD | ee775b56-0575-41e4-a948-c92a0bcd69b6 | 1 |
| 309291 | ciclopirox 8 % (nail lacquer) Topical Solution | SY | ee775b56-0575-41e4-a948-c92a0bcd69b6 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50383-419-03 | 50383041903 | 1 BOTTLE in 1 CARTON (50383-419-03) > 3.3 mL in 1 BOTTLE | 1 bottle | 2007-09-18 | 0000-00-00 | No | No | Current |
| 50383-419-06 | 50383041906 | 1 BOTTLE in 1 CARTON (50383-419-06) > 6.6 mL in 1 BOTTLE | 1 bottle | 2007-09-18 | 0000-00-00 | No | No | Current |