NDC codes

FDA NDC Directory
Product NDC (as listed)55681-303Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55681-0303Add 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
55681-303-035568103030355681030303300 TABLET in 1 BOTTLE (55681-303-03)Marketed from Mar 2, 2022

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)
ALLERGY RELIEF 10 mgSuffix: 10 mg
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
TWIN MED LLCNDC labeler code 55681
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210722
Marketing start
Listing expires
Identifiers
Product ID 55681-303_4e68e4e1-8a60-a8f1-e063-6394a90ac63bSPL ID 4e68e4e1-8a60-a8f1-e063-6394a90ac63bSPL set ID d943f548-aa0d-4476-e053-2a95a90a7bd4RxCUI 311372UNII 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

N455681030303 followed by a unit qualifier and the quantity

Package 55681-0303-03. 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 sneezing itchy, watery eyes 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 55681-303

What is NDC 55681-303?
55681-303 is the product NDC for ALLERGY RELIEF 10 mg (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by TWIN MED LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
ALLERGY RELIEF 10 mg (Loratadine).
What is the active ingredient?
Loratadine.
Who is the labeler?
TWIN MED LLC, NDC labeler code 55681. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ALLERGY RELIEF 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 210722

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

FDA NDC Directory listings under ANDA 210722
ProductStrengthForm · routeLabelerProduct NDC
Medi-First Plus Allery ReliefloratadineLoratadine 10 mg/1TabletOralUnifirst First Aid Corporation47682-912
24 / 7 Life Non-Drowsy Allergy Reliefloratadine tabletLoratadine 10 mg/1TabletOralLil' Drug Store Products, Inc.29485-8156
LoratadineLoratadine 10 mg/1TabletOralBryant Ranch Prepack71335-2431
LoratadineLoratadine 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8659
LoratadineLoratadine 10 mg/1TabletOralGRANULES USA, INC.69848-019
Allergy Reliefloratadine 10mgLoratadine 10 mg/1TabletOralFirst Aid Direct53117-414
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralAMERIFOODS TRADING COMPANY61504-193
CAREALL Allergy ReliefloratadineLoratadine 10 mg/1TabletOralNew World Imports51824-103
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralHARRIS TEETER72036-193
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralFSA STORE INC.81522-393
First Aid Direct Allergy Reliefloratadine tabletsLoratadine 10 mg/1TabletOralCintas Corporation42961-120
LoratadineLoratadine 10 mg/1TabletOralCamber Consumer Care Inc69230-328
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralWinCo Foods, LLC67091-493
Curist Allergy Reliefloratadine 10 mgLoratadine 10 mg/1TabletOralLittle Pharma, Inc.72559-033
LoratadineLoratadine 10 mg/1TabletOralAMZ789 LLC73629-003
Loratadine 10mgLoratadine 10 mg/1TabletOralMeijer79481-7870
Dr Simi All Day Allergy ReliefloratadineLoratadine 10 mg/1Tablet, Film coatedOralFarmacias De Similares TX LLC85786-201
LoratadineLoratadine 10 mg/1TabletOralWalgreens0363-9787
LoratadineLoratadine 10 mg/1TabletOralBryant Ranch Prepack71335-2529
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralAAA PHARMACEUTICAL, INC.57344-193

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