FLUTICASONE PROPIONATE
- Product NDC
- 0168-0332
- 11-digit product format
- 001680332
- Labeler code
- 0168
- Product ID
- 0168-0332_c1a3e651-d30b-49d5-8c5b-77a07006194f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluticasone propionate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Application
- ANDA076451
- Marketing category
- ANDA
- Marketing start
- 2004-05-14
- Substance
- FLUTICASONE PROPIONATE
- Active strength
- .5 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLUTICASONE PROPIONATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUTICASONE PROPIONATE | .5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O2GMZ0LF5W |
| Rxcui | 895987 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0168-0332-15 | 2025-08-11 | C162847 | 48780-1 | ab0e2407-2f27-f274-e053-dbdaa90a6471 | Fluticasone Propionate Cream USP, 0.05% |
| 0168-0332-30 | 2025-08-11 | C162847 | 48780-1 | ab0e2407-2f27-f274-e053-dbdaa90a6471 | Fluticasone Propionate Cream USP, 0.05% |
| 0168-0332-60 | 2025-08-11 | C162847 | 48780-1 | ab0e2407-2f27-f274-e053-dbdaa90a6471 | Fluticasone Propionate Cream USP, 0.05% |
| 0168-0332-15 | 2025-07-29 | C162847 | 48780-1 | ab0e2407-2f27-f274-e053-dbdaa90a6471 | Fluticasone Propionate Cream USP, 0.05% |
| 0168-0332-30 | 2025-07-29 | C162847 | 48780-1 | ab0e2407-2f27-f274-e053-dbdaa90a6471 | Fluticasone Propionate Cream USP, 0.05% |
| 0168-0332-60 | 2025-07-29 | C162847 | 48780-1 | ab0e2407-2f27-f274-e053-dbdaa90a6471 | Fluticasone Propionate Cream USP, 0.05% |
| 0168-0332-15 | 2020-09-17 | C162847 | 48780-1 | ab0e2407-2f27-f274-e053-dbdaa90a6471 | Fluticasone Propionate Cream USP, 0.05% |
| 0168-0332-30 | 2020-09-17 | C162847 | 48780-1 | ab0e2407-2f27-f274-e053-dbdaa90a6471 | Fluticasone Propionate Cream USP, 0.05% |
| 0168-0332-60 | 2020-09-17 | C162847 | 48780-1 | ab0e2407-2f27-f274-e053-dbdaa90a6471 | Fluticasone Propionate Cream USP, 0.05% |
| 0168-0332-15 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2f27-f274-e053-dbdaa90a6471 | Fluticasone Propionate Cream USP, 0.05% |
| 0168-0332-30 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2f27-f274-e053-dbdaa90a6471 | Fluticasone Propionate Cream USP, 0.05% |
| 0168-0332-60 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2f27-f274-e053-dbdaa90a6471 | Fluticasone Propionate Cream USP, 0.05% |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0168-0332-15 | FLUTICASONE PROPIONATE | 15 g in 1 TUBE | CREAM | 15 | | 9 |
| 0168-0332-30 | FLUTICASONE PROPIONATE | 30 g in 1 TUBE | CREAM | 30 | | 9 |
| 0168-0332-60 | FLUTICASONE PROPIONATE | 60 g in 1 TUBE | CREAM | 60 | | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0332 | FLUTICASONE PROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20200918_0e20d1cc-5c7a-4e0d-810b-b94c4d6dd1c0.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 |
|---|
| 0168-0332-15 | 00168033215 | 15 g in 1 TUBE (0168-0332-15) | 15 g | 2004-05-14 | 0000-00-00 | No | No | Current |
| 0168-0332-30 | 00168033230 | 30 g in 1 TUBE (0168-0332-30) | 30 g | 2004-05-14 | 0000-00-00 | No | No | Current |
| 0168-0332-60 | 00168033260 | 60 g in 1 TUBE (0168-0332-60) | 60 g | 2004-05-14 | 0000-00-00 | No | No | Current |