NDC codes

FDA NDC Directory
Product NDC (as listed)55111-551Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0551Add 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 NDC11-digit (billing)PackageCopy
55111-551-0655111055106551110551066 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-551-06)Marketed from Jan 11, 2013
55111-551-3155111055131551110551315 BLISTER PACK in 1 CARTON (55111-551-31) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jan 11, 2013

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 — 2.5 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
Labeler
Dr. Reddy's Laboratories LimitedNDC labeler code 55111
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078367
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 55111-551_ae8e6303-9bd6-d6de-79d6-d70b7b736c96SPL ID ae8e6303-9bd6-d6de-79d6-d70b7b736c96SPL set ID e5d1f465-e436-b4fd-d351-07a7b2acb440RxCUI 403841, 577080UNII FVF865388RUPC 0355111551317, 0355111360315
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

N455111055106 followed by a unit qualifier and the quantity

Package 55111-0551-06. 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)

Desloratadine is a histamine-1 (H 1 ) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. (1.1) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months 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 6 months of age and older. ( 1.3 ) 1.1 Seasonal Allergic Rhinitis Desloratadine orally disintegrating tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older. 1.2 Perennial Allergic Rhinitis De…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55111-551

What is NDC 55111-551?
55111-551 is the product NDC for Desloratadine, Desloratadine 2.5 mg/1 tablet, orally disintegrating, listed with the FDA by Dr. Reddy's Laboratories Limited. 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?
Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DesloratadineDesloratadine 5 mg/1TabletOralMorepen Bio Inc.87717-00187717-0001-0187717-0001-02
DesloratadineDesloratadine 5 mg/1Tablet, Film coatedOralNatco Pharma USA LLC69339-19469339-0194-0169339-0194-05
DesloratadineDesloratadine 5 mg/1Tablet, Film coatedOralBionpharma Inc.69452-36369452-0363-2069452-0363-30
DesloratadineDesloratadine 5 mg/1TabletOralA-S Medication Solutions50090-397550090-3975-0050090-3975-01
DesloratadineDesloratadine 5 mg/1TabletOralVirtus Pharmaceuticals, LLC69543-10769543-0107-1069543-0107-50
DesloratadineDesloratadine 5 mg/1TabletOralBryant Ranch Prepack72162-230872162-2308-0172162-2308-0372162-2308-05
DesloratadineDesloratadine 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-479450090-4794-00
DesloratadineDesloratadine 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-672450090-6724-00
DesloratadineDesloratadine 5 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-15368180-0153-0168180-0153-02
DesloratadineDesloratadine 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-100071335-1000-0171335-1000-0271335-1000-03

All 12 Desloratadine NDCs

Other NDCs under ANDA 078367

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078367
ProductStrengthForm · routeLabelerProduct NDC
DesloratadineDesloratadine 5 mg/1Tablet, Orally disintegratingOralDr. Reddy's Laboratories Limited55111-360

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