NDC codes

FDA NDC Directory
Product NDC (as listed)49483-686Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49483-0686Add 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
49483-686-07494830686074948306860710 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-07)Marketed from Oct 13, 2016
49483-686-30494830686304948306863030 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-30)Marketed from Oct 13, 2016

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
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 10 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
TIME CAP LABORATORIES INCNDC labeler code 49483
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206214
Marketing start
Listing expires
Identifiers
Product ID 49483-686_6c562c37-86ca-42c2-e053-2a91aa0a8a8aSPL ID 6c562c37-86ca-42c2-e053-2a91aa0a8a8aSPL set ID 85b26cf3-448c-4d4f-93a2-aa89530ec1f1RxCUI 828269UNII 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

N449483068607 followed by a unit qualifier and the quantity

Package 49483-0686-07. 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)

TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR 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 49483-686

What is NDC 49483-686?
49483-686 is the product NDC for Loratadine, Loratadine 10 mg/1 capsule, liquid filled, listed with the FDA by TIME CAP LABORATORIES INC. It has 2 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?
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?
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/1TabletOralPreferred Pharmaceuticals Inc.68788-865968788-8659-0068788-8659-0168788-8659-03+2 more
LoratadineLoratadine 10 mg/1Tablet, Orally disintegratingOralTenshi Kaizen Pvt Ltd72983-50372983-0503-06

All 110 Loratadine NDCs

Other NDCs under ANDA 206214

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

FDA NDC Directory listings under ANDA 206214
ProductStrengthForm · routeLabelerProduct NDC
Allergy ReliefloratadineLoratadine 10 mg/1Capsule, Liquid filledOralTARGET CORPORATION11673-986
Allergy ReliefloratadineLoratadine 10 mg/1Capsule, Liquid filledOralSafeway21130-195
Allergy ReliefloratadineLoratadine 10 mg/1Capsule, Liquid filledOralCARDINAL HEALTH 110, LLC. DBA LEADER70000-0755
Allergy ReliefloratadineLoratadine 10 mg/1Capsule, Liquid filledOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-103
LoratadineLoratadine 10 mg/1Capsule, Liquid filledOralMARKSANS PHARMA LIMITED25000-021
LoratadineLoratadine 10 mg/1Capsule, Liquid filledOralKROGER COMPANY41226-686
LoratadineLoratadine 10 mg/1Capsule, Liquid filledOralSMART SENSE (KMART)49738-686
LoratadineLoratadine 10 mg/1Capsule, Liquid filledOralCVS HEALTH CORP69842-686
Wal-ItinloratadineLoratadine 10 mg/1Capsule, Liquid filledOralWALGREENS0363-1686

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