Over-the-counter drug · ANDA
Childrens Allergy (Fluticasone propionate) NDC 51316-197
Fluticasone propionate 50 ug/1 · Spray, Metered · Nasal · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC codes
FDA NDC DirectoryProduct NDC (as listed)51316-197Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0197Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-197-08 | 5131601970851316019708 | 1 BOTTLE in 1 CARTON (51316-197-08) / 72 SPRAY, METERED in 1 BOTTLEMarketed from Jun 12, 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)
- Childrens Allergy
- Generic name (nonproprietary)
- fluticasone propionate
- Active ingredients
- Fluticasone propionate — 50 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNDC labeler code 51316
- 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 51316-197_a8280495-9b25-4489-95c2-2e7b55789674SPL ID a8280495-9b25-4489-95c2-2e7b55789674SPL set ID b9b3efe4-2f5c-4d22-80a4-d15fb266fb23RxCUI 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
N451316019708followed by a unit qualifier and the quantityPackage 51316-0197-08. 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 • runny nose • sneezing • itchy nose • itchy, watery eyes
Excerpt only. Read the full label for complete information.
About NDC 51316-197
- What is NDC 51316-197?
- 51316-197 is the product NDC for Childrens Allergy (fluticasone propionate), Fluticasone propionate 50 ug/1 spray, metered, listed with the FDA by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Allergy (Fluticasone Propionate).
- What is the active ingredient?
- Fluticasone propionate.
- Who is the labeler?
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Childrens Allergy?
- 25 other product NDCs are listed under this name. See all Childrens Allergy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens Allergy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | WALMART INC. (see also Equate) | 79903-249 | 79903-0249-04 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | CVS PHARMACY, INC | 51316-260 | 51316-0260-04 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Family Dollar (FAMILY WELLNESS) | 55319-923 | 55319-0923-04 |
| Childrens Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | KinderFarms, LLC | 82673-109 | 82673-0109-04 |
| Childrens Allergyfexofenadine hydrochloride | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | H2-Pharma, LLC | 61269-527 | 61269-0527-94 |
| Childrens Allergydiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Genexa Inc. | 69676-0074 | 69676-0074-09 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | H E B | 37808-623 | 37808-0623-04 |
| Childrens Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | AptaPharma Inc. | 76281-505 | 76281-0505-24 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-208 | 49035-0208-04 |
| childrens allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Kroger Company | 30142-651 | 30142-0651-2630142-0651-34 |
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 |
|---|---|---|---|---|
| Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-497 |
| Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Meijer Distribution Inc | 41250-634 |
| leader fluticasone propionatefluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Cardinal Health 110, LLC. dba Leader | 70000-0703 |
| Nasopro 24fluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | H E B | 37808-205 |
| good neighbor pharmacy fluticasone propionatefluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Amerisource Bergen | 46122-684 |
| careone childrens allergy relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | American Sales Company | 41520-553 |
| Equate Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | WALMART INC. | 79903-071 |
| basic care allergy relief nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Amazon.com Services LLC | 72288-119 |
| Good Sense 24 hour allergy nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | L. Perrigo Company | 0113-0285 |
| Equaline Fluticasone Propionatefluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | United Natural Foods, Inc. dba UNFI | 41163-023 |
| DG Health Allergy Relief Nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Dolgencorp Inc | 55910-773 |
| CareOne Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | American Sales Company | 41520-703 |
| Childrens Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Walgreen Company | 0363-4023 |
| Childrens Nasoprofluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | H E B | 37808-340 |
| allergy relief nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | HyVee Inc | 42507-710 |
| Good Sense 24 hour allergy nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | RedPharm Drug, Inc | 67296-1463 |
| childrens allergy relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Safeway | 21130-607 |
| Rugby Fluticasone Propionate Nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Sportpharm LLC | 85766-161 |
| basic care childrens allergy relief nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Amazon.com Services LLC | 72288-333 |
| Rugby Fluticasone Propionate Nasalfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | ASCLEMED USA INC. | 87063-114 |
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