Prescription drug · ANDA
Desloratadine NDC 50090-3975
Desloratadine 5 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3975-0 | 5009039750050090397500 | 90 TABLET in 1 BOTTLE (50090-3975-0)Marketed from Dec 13, 2018 | |
| 50090-3975-1 | 5009039750150090397501 | 30 TABLET in 1 BOTTLE (50090-3975-1)Marketed from Dec 6, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078355
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50090-3975_435e054f-b898-4718-90d6-cfa9f98077f9SPL ID 435e054f-b898-4718-90d6-cfa9f98077f9SPL set ID 36307c2b-6b6a-46a9-9fe4-1798fc72e7b8RxCUI 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
N450090397500followed by a unit qualifier and the quantityPackage 50090-3975-00. 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 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 Deslo…
Excerpt only. Read the full label for complete information.
About NDC 50090-3975
- What is NDC 50090-3975?
- 50090-3975 is the product NDC for Desloratadine, Desloratadine 5 mg/1 tablet, listed with the FDA by A-S Medication Solutions. 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?
- A-S Medication Solutions, NDC labeler code 50090. 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.
Related NDCs: other Desloratadine products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-363 | 69452-0363-2069452-0363-30 |
| 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 |
Other NDCs under ANDA 078355
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 |
|---|---|---|---|---|
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | Virtus Pharmaceuticals, LLC | 69543-107 |
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2308 |
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | Morepen Bio Inc. | 87717-001 |