NDC codes

FDA NDC Directory
Product NDC (as listed)0363-9985Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-9985Add 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
0363-9985-30003639985303 BLISTER PACK in 1 CARTON (0363-9985-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Mar 15, 2024
0363-9985-60003639985606 BLISTER PACK in 1 CARTON (0363-9985-60) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Mar 15, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 5 mg/1
Dosage form
Tablet, Chewable
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210088
Marketing start
Listing expires
Identifiers
Product ID 0363-9985_275123ff-399a-9195-e063-6294a90af2b4SPL ID 275123ff-399a-9195-e063-6294a90af2b4SPL set ID c9e12155-a699-4fa7-aac8-da7d5ddab4aeRxCUI 665078UNII 7AJO3BO7QN

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

N400363998530 followed by a unit qualifier and the quantity

Package 00363-9985-30. 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)

Other NDCs under ANDA 210088

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

FDA NDC Directory listings under ANDA 210088
ProductStrengthForm · routeLabelerProduct NDC
Dye-Free Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralOhm Laboratories Inc.51660-112
Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralSAFEWAY21130-999
Wal-itinloratadineLoratadine 5 mg/1Tablet, ChewableOralWALGREENS CO.0363-9995
Dye-Free Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralUP & UP11673-115
Dye-Free Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralCVS PHARMACY, INC51316-821
Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralOhm Laboratories Inc.51660-754
Dye-Free Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralOhm Laboratories Inc.51660-726
LoratadineLoratadine 5 mg/1Tablet, ChewableOralOhm Laboratories Inc.51660-753
Dye-Free LoratadineloratadineLoratadine 10 mg/1Tablet, ChewableOralOhm Laboratories Inc.51660-755
Dye-Free Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralWAL-MART STORES, INC79903-008
Dye-Free Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralSAFEWAY21130-646
Dye-Free Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralWAL-MART STORES, INC79903-330
Dye-Free Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralCVS PHARMACY, INC69842-894
Dye-Free Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralCVS PHARMACY, INC69842-895
Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralTARGET CORPORATION11673-310
LoratadineLoratadine 5 mg/1Tablet, ChewableOralKROGER COMPANY30142-984
LoratadineLoratadine 5 mg/1Tablet, ChewableOralKROGER COMPANY30142-996
Curist Childrens Allergy Reliefloratadine 5 mg chewable tabletsLoratadine 5 mg/1Tablet, ChewableOralLittle Pharma, Inc.72559-031
Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralCVS PHARMACY, INC69842-953
Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralCVS PHARMACY, INC69842-954

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