Over-the-counter drug · ANDA
TopCare Childrens Allergy Relief Nasal 24 Hour (Fluticasone propionate) NDC 36800-128
Fluticasone propionate 50 ug/1 · Spray, Metered · Nasal · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-128-08 | 3680001280836800012808 | 1 BOTTLE, SPRAY in 1 CARTON (36800-128-08) / 72 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Aug 17, 2021 |
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 Childrens Allergy Relief Nasal 24 Hour
- Generic name (nonproprietary)
- fluticasone propionate
- Active ingredients
- Fluticasone propionate — 50 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207957
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 36800-128_824a15b1-df5d-4d36-9a12-0d67a9c7a5bcSPL ID 824a15b1-df5d-4d36-9a12-0d67a9c7a5bcSPL set ID 3eeab9c9-82db-4d03-b4ba-34c1d6f1b1a9RxCUI 1797907UNII O2GMZ0LF5W
- 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
N436800012808followed by a unit qualifier and the quantityPackage 36800-0128-08. 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 • itchy nose • runny nose • itchy, watery eyes • sneezing
Excerpt only. Read the full label for complete information.
About NDC 36800-128
- What is NDC 36800-128?
- 36800-128 is the product NDC for TopCare Childrens Allergy Relief Nasal 24 Hour, Fluticasone propionate 50 ug/1 spray, metered, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- TopCare Childrens Allergy Relief Nasal 24 Hour (Fluticasone Propionate).
- What is the active ingredient?
- Fluticasone propionate.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. 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 Childrens Allergy Relief Nasal 24 Hour?
- 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 ANDA 207957
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 |
|---|---|---|---|---|
| 24 Hour Allergy Nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Walgreen Company | 0363-0024 |
| allergy nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Rite Aid Corporation | 11822-0901 |
| allergy nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-181 |
| allergy relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Safeway | 21130-863 |
| Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Meijer Distribution Inc | 41250-634 |
| Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-497 |
| allergy relief nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | HyVee Inc | 42507-710 |
| allergy relief nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Publix Super Markets Inc | 56062-107 |
| Allergy Relief Nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Amazon.com Services LLC | 72288-349 |
| basic care allergy relief nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Amazon.com Services LLC | 72288-119 |
| basic care childrens allergy relief nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Amazon.com Services LLC | 72288-333 |
| CareOne Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | American Sales Company | 41520-703 |
| careone childrens allergy relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | American Sales Company | 41520-553 |
| Childrens Allergyfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-197 |
| Childrens Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Walgreen Company | 0363-4023 |
| childrens allergy relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Safeway | 21130-607 |
| childrens allergy relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-818 |
| Childrens Nasoprofluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | H E B | 37808-340 |
| DG Health Allergy Relief Nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Dolgencorp Inc | 55910-773 |
| DG Health childrens allergy relief nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Dolgencorp Inc | 55910-607 |
Showing 20 of 39.