Prescription drug · ANDA
Mometasone Furoate NDC 45802-257
Mometasone furoate 1 mg/g · Cream · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-257-35 | 4580202573545802025735 | 1 TUBE in 1 CARTON (45802-257-35) / 15 g in 1 TUBEMarketed from Apr 5, 2024 | |
| 45802-257-42 | 4580202574245802025742 | 1 TUBE in 1 CARTON (45802-257-42) / 45 g in 1 TUBEMarketed from Apr 5, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Mometasone Furoate
- Generic name (nonproprietary)
- mometasone furoate
- Active ingredients
- Mometasone furoate — 1 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076679
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 45802-257_395c6e1e-e5c9-f36a-e063-6294a90a48d7SPL ID 395c6e1e-e5c9-f36a-e063-6294a90a48d7SPL set ID a12fef6b-681e-4f80-8bcd-3f01733f1a67RxCUI 311753UNII 04201GDN4R
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N445802025735followed by a unit qualifier and the quantityPackage 45802-0257-35. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Mometasone Furoate Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. Mometasone Furoate Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥2 years of age. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 45802-257
- What is NDC 45802-257?
- 45802-257 is the product NDC for Mometasone Furoate, Mometasone furoate 1 mg/g cream, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mometasone Furoate.
- What is the active ingredient?
- Mometasone furoate.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mometasone Furoate?
- 35 other product NDCs are listed under this name. See all Mometasone Furoate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mometasone Furoate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mometasone furoate | Mometasone furoate 1 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-071 | 21922-0071-0421922-0071-06 |
| Mometasone Furoate | Mometasone furoate 1 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-4075 | 68788-4075-04 |
| Mometasone Furoate | Mometasone furoate 1 mg/mL | LotionTopical | Encube Ethicals, Inc. | 21922-072 | 21922-0072-0121922-0072-21 |
| Mometasone Furoate | Mometasone furoate 1 mg/1 | OintmentTopical | Torrent Pharmaceuticals Limited | 13668-527 | 13668-0527-0113668-0527-04 |
| Mometasone Furoate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | Aurohealth LLC | 58602-522 | 58602-0522-44 |
| Mometasone Furoate | Mometasone furoate 1 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8548 | 68788-8548-04 |
| Mometasone Furoate | Mometasone furoate 1 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-8357 | 68788-8357-04 |
| Mometasone Furoate | Mometasone furoate 1 mg/mL | LotionTopical | Glenmark Pharmaceuticals Inc., USA | 68462-385 | 68462-0385-0268462-0385-37 |
| Mometasone Furoatemometasone | Mometasone furoate 50 ug/1 | Spray, MeteredNasal | Amneal Pharmaceuticals LLC | 65162-891 | 65162-0891-29 |
| Mometasone Furoate | Mometasone 50 ug/1 | Spray, MeteredNasal | Golden State Medical Supply, Inc. | 60429-664 | 60429-0664-17 |
Other NDCs under ANDA 076679
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Mometasone Furoate | Mometasone furoate 1 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-1315 |
| Mometasone Furoate | Mometasone furoate 1 mg/g | CreamTopical | Proficient Rx LP | 63187-288 |
| Mometasone Furoate | Mometasone furoate 1 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8681 |
| Mometasone Furoate | Mometasone furoate 1 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8682 |
| Mometasone Furoate | Mometasone furoate 1 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8548 |
| Mometasone Furoate | Mometasone furoate 1 mg/g | CreamTopical | Bryant Ranch Prepack | 71335-2873 |
| Mometasone Furoate | Mometasone furoate 1 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1404 |