Mometasone Furoate
- Product NDC
- 68462-385
- 11-digit product format
- 684620385
- Labeler code
- 68462
- Product ID
- 68462-385_fca48ee3-83aa-4615-9aa2-d8e8b2550069
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mometasone Furoate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA090506
- Marketing category
- ANDA
- Marketing start
- 2020-06-01
- Substance
- MOMETASONE FUROATE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], 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
- Mometasone Furoate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MOMETASONE FUROATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04201GDN4R |
| Rxcui | 151030 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-385-02 | Mometasone Furoate | 60 mL in 1 BOTTLE | LOTION | 60 | | 10 |
| 68462-385-02 | Mometasone Furoate | 1 in 1 CARTON | LOTION | 1 | | 10 |
| 68462-385-37 | Mometasone Furoate | 1 in 1 CARTON | LOTION | 1 | | 10 |
| 68462-385-37 | Mometasone Furoate | 30 mL in 1 BOTTLE | LOTION | 30 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MOMETASONE FUROATE | ACTIVE INGREDIENT | 04201GDN4R | MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| MOMETASONE | ACTIVE MOIETY | 8HR4QJ6DW8 | MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| PHOSPHORIC ACID | INACTIVE INGREDIENT | E4GA8884NN | MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-385 | MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA] | 10 | Current NDC, Legacy NDC, 4 package rows | 20240104_96eafc06-0354-49ca-a684-a77bb2afc8f5.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 |
|---|
| 68462-385-02 | 68462038502 | 1 BOTTLE in 1 CARTON (68462-385-02) / 60 mL in 1 BOTTLE | 1 bottle | 2020-06-01 | 0000-00-00 | No | No | Current |
| 68462-385-37 | 68462038537 | 1 BOTTLE in 1 CARTON (68462-385-37) / 30 mL in 1 BOTTLE | 1 bottle | 2020-06-01 | 0000-00-00 | No | No | Current |