Fluticasone Propionate
- Product NDC
- 0713-0631
- 11-digit product format
- 007130631
- Labeler code
- 0713
- Product ID
- 0713-0631_de485a69-2992-143b-e053-2a95a90a4b89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluticasone Propionate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA077055
- Marketing category
- ANDA
- Marketing start
- 2006-06-30
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0631-15 | Fluticasone Propionate | 1 in 1 CARTON | CREAM | 1 | | 11 |
| 0713-0631-15 | Fluticasone Propionate | 15 g in 1 TUBE | CREAM | 15 | | 11 |
| 0713-0631-31 | Fluticasone Propionate | 1 in 1 CARTON | CREAM | 1 | | 11 |
| 0713-0631-31 | Fluticasone Propionate | 30 g in 1 TUBE | CREAM | 30 | | 11 |
| 0713-0631-60 | Fluticasone Propionate | 60 g in 1 TUBE | CREAM | 60 | | 11 |
| 0713-0631-60 | Fluticasone Propionate | 1 in 1 CARTON | CREAM | 1 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Fluticasone Propionate | ACTIVE INGREDIENT | O2GMZ0LF5W | FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] | 7 | |
| Fluticasone | ACTIVE MOIETY | CUT2W21N7U | FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] | 7 | |
| Ceteth-20 | INACTIVE INGREDIENT | I835H2IHHX | FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] | 7 | |
| Cetostearyl Alcohol | INACTIVE INGREDIENT | 2DMT128M1S | FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] | 7 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] | 7 | |
| Isopropyl Myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] | 7 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] | 7 | |
| Mineral Oil | INACTIVE INGREDIENT | T5L8T28FGP | FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] | 7 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] | 7 | |
| Sodium Phosphate, Dibasic | INACTIVE INGREDIENT | GR686LBA74 | FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] | 7 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] | 7 | |
| Fluticasone Propionate | ACTIVE INGREDIENT | O2GMZ0LF5W | FLUTICASONE PROPIONATE CREAM [DIRECT RX] | 4 | |
| FLUTICASONE | ACTIVE MOIETY | CUT2W21N7U | FLUTICASONE PROPIONATE CREAM [DIRECT RX] | 4 | |
| Ceteth-20 | INACTIVE INGREDIENT | I835H2IHHX | FLUTICASONE PROPIONATE CREAM [DIRECT RX] | 4 | |
| Cetostearyl Alcohol | INACTIVE INGREDIENT | 2DMT128M1S | FLUTICASONE PROPIONATE CREAM [DIRECT RX] | 4 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | FLUTICASONE PROPIONATE CREAM [DIRECT RX] | 4 | |
| Isopropyl Myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | FLUTICASONE PROPIONATE CREAM [DIRECT RX] | 4 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | FLUTICASONE PROPIONATE CREAM [DIRECT RX] | 4 | |
| Mineral Oil | INACTIVE INGREDIENT | T5L8T28FGP | FLUTICASONE PROPIONATE CREAM [DIRECT RX] | 4 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | FLUTICASONE PROPIONATE CREAM [DIRECT RX] | 4 | |
| Sodium Phosphate, Dibasic | INACTIVE INGREDIENT | GR686LBA74 | FLUTICASONE PROPIONATE CREAM [DIRECT RX] | 4 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | FLUTICASONE PROPIONATE CREAM [DIRECT RX] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0631 | FLUTICASONE PROPIONATE CREAM [COSETTE PHARMACEUTICALS, INC.] | 11 | Current NDC, Legacy NDC, 6 package rows | 20220616_14c8d082-b301-8f09-a509-950459ae0a28.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 |
|---|
| 0713-0631-15 | 00713063115 | 1 TUBE in 1 CARTON (0713-0631-15) / 15 g in 1 TUBE | 1 tube | 2006-06-30 | 0000-00-00 | No | No | Current |
| 0713-0631-31 | 00713063131 | 1 TUBE in 1 CARTON (0713-0631-31) / 30 g in 1 TUBE | 1 tube | 2006-06-30 | 0000-00-00 | No | No | Current |
| 0713-0631-60 | 00713063160 | 1 TUBE in 1 CARTON (0713-0631-60) / 60 g in 1 TUBE | 1 tube | 2006-06-30 | 0000-00-00 | No | No | Current |