NDC codes

FDA NDC Directory
Product NDC (as listed)49483-732Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49483-0732Add 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
49483-732-654948307326549483073265365 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

N449483073265 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under ANDA 219223
ProductStrengthForm · routeLabelerProduct NDC
Loratadine 10mgLoratadine 10 mg/1TabletOralMARKSANS PHARMA LIMITED25000-092

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in