Fluticasone Propionate
- Product NDC
- 68462-427
- 11-digit product format
- 684620427
- Labeler code
- 68462
- Product ID
- 68462-427_033b2fba-d1e5-4bb5-8b20-005d905056bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluticasone Propionate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA090759
- Marketing category
- ANDA
- Marketing start
- 2011-10-13
- Substance
- FLUTICASONE PROPIONATE
- Active strength
- .5 mg/mL
- 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/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O2GMZ0LF5W |
| Rxcui | 895990 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-427-02 | Fluticasone Propionate | 1 in 1 CARTON | LOTION | 1 | | 10 |
| 68462-427-02 | Fluticasone Propionate | 60 mL in 1 BOTTLE | LOTION | 60 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUTICASONE PROPIONATE | ACTIVE INGREDIENT | O2GMZ0LF5W | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| FLUTICASONE | ACTIVE MOIETY | CUT2W21N7U | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| ANHYDROUS TRISODIUM CITRATE | INACTIVE INGREDIENT | RS7A450LGA | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| DIMETHICONE 350 | INACTIVE INGREDIENT | 2Y53S6ATLU | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| IMIDUREA | INACTIVE INGREDIENT | M629807ATL | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| POLYOXYL 20 CETOSTEARYL ETHER | INACTIVE INGREDIENT | YRC528SWUY | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-427 | FLUTICASONE PROPIONATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240104_3c7b3482-e2fd-4857-9394-a47fd7f4c47b.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 |
|---|
| 68462-427-02 | 68462042702 | 1 BOTTLE in 1 CARTON (68462-427-02) / 60 mL in 1 BOTTLE | 1 bottle | 2011-10-13 | 0000-00-00 | No | No | Current |