What is NDC 69452-363?

69452-363 is the product NDC for Desloratadine, Desloratadine 5 mg/1 tablet, film coated, listed with the FDA by Bionpharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Bionpharma Inc., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Desloratadine?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Desloratadine NDC 69452-363 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-363Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0363Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
69452-363-20	6945203632069452036320	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-20)Marketed from Nov 28, 2023
69452-363-30	6945203633069452036330	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-30)Marketed from Nov 28, 2023

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): Desloratadine
Generic name (nonproprietary): desloratadine
Active ingredients: Desloratadine — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bionpharma Inc.NDC labeler code 69452
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078357
Marketing start: Nov 28, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 69452-363_63a77a01-b991-4f03-8f9f-4dd09c8302c4SPL ID 63a77a01-b991-4f03-8f9f-4dd09c8302c4SPL set ID 4d094001-b85a-47b3-bc67-a46660384eceRxCUI 349420UNII FVF865388R
Pharmacologic class: Histamine-1 Receptor Antagonist

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469452036320 followed by a unit qualifier and the quantity

Package 69452-0363-20. 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 Nov 27, 2023.

Indications (excerpt from the label)

Desloratadine tablets are a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. (1.1) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. (1.2) Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 12 years of age and older. (1.3) 1.1 Seasonal Allergic Rhinitis Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older. 1.2 Perennial Allergic Rhinitis Desloratadine tab…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69452-363

What is NDC 69452-363?: 69452-363 is the product NDC for Desloratadine, Desloratadine 5 mg/1 tablet, film coated, listed with the FDA by Bionpharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Desloratadine.
What is the active ingredient?: Desloratadine.
Who is the labeler?: Bionpharma Inc., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Desloratadine?: 11 other product NDCs are listed under this name. See all Desloratadine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Desloratadine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Desloratadine	Desloratadine 5 mg/1	TabletOral	Morepen Bio Inc.	87717-001	87717-0001-0187717-0001-02
Desloratadine	Desloratadine 5 mg/1	Tablet, Film coatedOral	Natco Pharma USA LLC	69339-194	69339-0194-0169339-0194-05
Desloratadine	Desloratadine 5 mg/1	TabletOral	A-S Medication Solutions	50090-3975	50090-3975-0050090-3975-01
Desloratadine	Desloratadine 5 mg/1	TabletOral	Virtus Pharmaceuticals, LLC	69543-107	69543-0107-1069543-0107-50
Desloratadine	Desloratadine 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2308	72162-2308-0172162-2308-0372162-2308-05
Desloratadine	Desloratadine 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4794	50090-4794-00
Desloratadine	Desloratadine 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6724	50090-6724-00
Desloratadine	Desloratadine 5 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-153	68180-0153-0168180-0153-02
Desloratadine	Desloratadine 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1000	71335-1000-0171335-1000-0271335-1000-03
Desloratadine	Desloratadine 5 mg/1	Tablet, Orally disintegratingOral	Dr. Reddy's Laboratories Limited	55111-360	55111-0360-0655111-0360-31

All 12 Desloratadine NDCs