Over-the-counter drug · ANDA
Loratadine 10 mg (Loratadine tablets usp, 10 mg) NDC 49483-732
Loratadine 10 mg/1 · Tablet · Oral · TIME CAP LABORATORIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-732-65 | 4948307326549483073265 | 365 TABLET in 1 BOTTLE (49483-732-65)Marketed from Jan 25, 2025 |
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)
- Loratadine 10 mg
- Generic name (nonproprietary)
- loratadine tablets usp, 10 mg
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INC.NDC labeler code 49483
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219223
- Marketing start
- Listing expires
- Identifiers
- Product ID 49483-732_2c80ea14-8491-4d26-e063-6294a90aecf0SPL ID 2c80ea14-8491-4d26-e063-6294a90aecf0SPL set ID 2c80ea14-8490-4d26-e063-6294a90aecf0RxCUI 311372UNII 7AJO3BO7QNUPC 0349483732658
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
N449483073265followed by a unit qualifier and the quantityPackage 49483-0732-65. 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 due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 49483-732
- What is NDC 49483-732?
- 49483-732 is the product NDC for Loratadine 10 mg, Loratadine 10 mg/1 tablet, listed with the FDA by TIME CAP LABORATORIES, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loratadine 10 mg (Loratadine Tablets USP, 10 mg).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- TIME CAP LABORATORIES, INC., NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Loratadine 10 mg?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 219223
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 |
|---|---|---|---|---|
| Loratadine 10mg | Loratadine 10 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-092 |