NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8659Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8659Add 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
68788-8659-0687888659006878886590010 TABLET in 1 BOTTLE (68788-8659-0)Marketed from May 13, 2024
68788-8659-1687888659016878886590114 TABLET in 1 BOTTLE (68788-8659-1)Marketed from May 13, 2024
68788-8659-3687888659036878886590330 TABLET in 1 BOTTLE (68788-8659-3)Marketed from May 13, 2024
68788-8659-5687888659056878886590515 TABLET in 1 BOTTLE (68788-8659-5)Marketed from May 13, 2024
68788-8659-9687888659096878886590990 TABLET in 1 BOTTLE (68788-8659-9)Marketed from May 13, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210722
Marketing start
Listing expires
Identifiers
Product ID 68788-8659_e547e609-2932-459e-9195-216c2794c11cSPL ID e547e609-2932-459e-9195-216c2794c11cSPL set ID c6144a33-6b33-4aca-86e5-a3f688b8b317RxCUI 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

N468788865900 followed by a unit qualifier and the quantity

Package 68788-8659-00. 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)

USE(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, water 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 68788-8659

What is NDC 68788-8659?
68788-8659 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Loratadine.
What is the active ingredient?
Loratadine.
Who is the labeler?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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?
109 other product NDCs are listed under this name. See all Loratadine NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Loratadine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LoratadineLoratadine 10 mg/1TabletOralYYBA CORP73581-22973581-0229-0173581-0229-03
LoratadineLoratadine 10 mg/1TabletOralAvPAK50268-77750268-0777-01
LoratadineLoratadine 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-410368788-4103-0068788-4103-0168788-4103-03+2 more
LoratadineLoratadine 10 mg/1TabletOralSafecor Health, LLC48433-06448433-0064-20
LoratadineLoratadine 10 mg/1TabletOralAurobindo Pharma Limited84386-11984386-0119-78
LoratadineLoratadine 10 mg/1TabletOralCabinet Health P.B.C.82725-014282725-0142-0182725-0142-0282725-0142-03+1 more
LoratadineLoratadine 10 mg/1TabletOralCardinal Health 107, LLC55154-018855154-0188-00
LoratadineLoratadine 10 mg/1TabletOralMajor Pharmaceuticals0904-751100904-7511-61
LoratadineLoratadine 10 mg/1Tablet, Orally disintegratingOralTenshi Kaizen Pvt Ltd72983-50372983-0503-06
LoratadineLoratadine 10 mg/1TabletOralPreferred Pharmaceuticals Inc68788-861668788-8616-0068788-8616-0168788-8616-03+3 more

All 110 Loratadine NDCs

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/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 RELIEF 10 mgloratadineLoratadine 10 mg/1TabletOralTWIN MED LLC55681-303
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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