Prescription drug · ANDA
Desloratadine NDC 69339-194
Desloratadine 5 mg/1 · Tablet, Film coated · Oral · Natco Pharma USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69339-194-01 | 6933901940169339019401 | 100 TABLET, FILM COATED in 1 BOTTLE (69339-194-01)Marketed from Apr 1, 2026 | |
| 69339-194-05 | 6933901940569339019405 | 500 TABLET, FILM COATED in 1 BOTTLE (69339-194-05)Marketed from Apr 1, 2026 |
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
- Natco Pharma USA LLCNDC labeler code 69339
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078351
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69339-194_e4db30a5-48e5-4fe3-8793-30b6866f87c1SPL ID e4db30a5-48e5-4fe3-8793-30b6866f87c1SPL set ID e4db30a5-48e5-4fe3-8793-30b6866f87c1RxCUI 349420UNII FVF865388RUPC 0369339194010, 0369339194058
- 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
N469339019401followed by a unit qualifier and the quantityPackage 69339-0194-01. 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 Desloratadi…
Excerpt only. Read the full label for complete information.
About NDC 69339-194
- What is NDC 69339-194?
- 69339-194 is the product NDC for Desloratadine, Desloratadine 5 mg/1 tablet, film coated, listed with the FDA by Natco Pharma USA LLC. 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?
- Natco Pharma USA LLC, NDC labeler code 69339. 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 | Bionpharma Inc. | 69452-363 | 69452-0363-2069452-0363-30 |
| 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 |