Over-the-counter drug · NDA
topcare allergy (Mometasone furoate monohydrate) NDC 76162-134
Mometasone furoate monohydrate 50 ug/1 · Spray, Metered · Nasal · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76162-134-02 | 7616201340276162013402 | 1 BOTTLE, SPRAY in 1 CARTON (76162-134-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Mar 28, 2023 | |
| 76162-134-11 | 7616201341176162013411 | 1 BOTTLE, SPRAY in 1 CARTON (76162-134-11) / 60 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Mar 14, 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)
- topcare allergy
- Generic name (nonproprietary)
- mometasone furoate monohydrate
- Active ingredients
- Mometasone furoate monohydrate — 50 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Topco Associates LLCNDC labeler code 76162
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215712
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 76162-134_cbd64cee-c8fe-4d6d-b3cf-561238b4a0a5SPL ID cbd64cee-c8fe-4d6d-b3cf-561238b4a0a5SPL set ID 9e7c759e-d2cb-4505-ad9f-38efaaaeefc2RxCUI 1797865UNII MTW0WEG809
- 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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476162013402followed by a unit qualifier and the quantityPackage 76162-0134-02. 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)
Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose
Excerpt only. Read the full label for complete information.
About NDC 76162-134
- What is NDC 76162-134?
- 76162-134 is the product NDC for topcare allergy (mometasone furoate monohydrate), Mometasone furoate monohydrate 50 ug/1 spray, metered, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- topcare allergy (Mometasone furoate monohydrate).
- What is the active ingredient?
- Mometasone furoate monohydrate.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 76162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for topcare allergy?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 215712
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 |
|---|---|---|---|---|
| Allergymometasone furoate monohydrate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | Rite Aid Corporation | 11822-7099 |
| allergymometasone furoate monohydrate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | HyVee Inc | 42507-182 |
| allergymometasone furoate monohydrate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-117 |
| Allergymometasone furoate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | Amazon.com Services LLC | 72288-506 |
| allergy nasalmometasone furoate monohydrate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | Walgreen Company | 0363-2060 |
| Allergy Reliefmometasone furoate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-172 |
| basic care allergymometasone furoate monohydrate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | Amazon.com Services LLC | 72288-610 |
| Childrens Nasonexmometasone furoate | Mometasone furoate 50 ug/1 | Spray, MeteredNasal | L. Perrigo Company | 0113-1999 |
| Leader Allergy Nasalmometasone furoate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | Cardinal Health 110, LLC. dba Leader | 70000-0635 |
| Nasonexmometasone furoate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | L. Perrigo Company | 0113-1720 |
| Rugby mometasone furoate nasalmometasone furoate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | Rugby Laboratories | 0536-1381 |