NDC codes

FDA NDC Directory
Product NDC (as listed)0363-0858Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0858Add 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
0363-0858-0300363085803003630858031 BOTTLE, PLASTIC in 1 BOX (0363-0858-03) / 30 TABLET in 1 BOTTLE, PLASTICMarketed from Sep 30, 2018
0363-0858-0500363085805003630858055 BLISTER PACK in 1 CARTON (0363-0858-05) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 30, 2018
0363-0858-10003630858100036308581010 BLISTER PACK in 1 CARTON (0363-0858-10) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 30, 2018
0363-0858-1500363085815003630858151 BOTTLE, PLASTIC in 1 CARTON (0363-0858-15) / 150 TABLET in 1 BOTTLE, PLASTICMarketed from Sep 30, 2018
0363-0858-20003630858200036308582020 BLISTER PACK in 1 CARTON (0363-0858-20) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 30, 2018
0363-0858-3000363085830003630858301 BOTTLE, PLASTIC in 1 BOX (0363-0858-30) / 300 TABLET in 1 BOTTLE, PLASTICMarketed from Sep 30, 2018
0363-0858-4500363085845003630858451 BOTTLE, PLASTIC in 1 BOX (0363-0858-45) / 45 TABLET in 1 BOTTLE, PLASTICMarketed from Sep 30, 2018
0363-0858-7000363085870003630858701 BOTTLE, PLASTIC in 1 BOX (0363-0858-70) / 70 TABLET in 1 BOTTLE, PLASTICMarketed from Sep 30, 2018
0363-0858-9000363085890003630858901 BOTTLE, PLASTIC in 1 BOX (0363-0858-90) / 90 TABLET in 1 BOTTLE, PLASTICMarketed from Sep 30, 2018

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)
Indoor Outdoor Allergy Relief
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
WalgreensNDC labeler code 0363
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075209
Marketing start
Listing expires
Identifiers
Product ID 0363-0858_a69e70f5-0044-4834-b033-571f9c36caadSPL ID a69e70f5-0044-4834-b033-571f9c36caadSPL set ID 19fb573f-29a1-4166-becb-0698cfbb682cRxCUI 311372UNII 7AJO3BO7QNUPC 0311917202051

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

N400363085803 followed by a unit qualifier and the quantity

Package 00363-0858-03. 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 0363-0858

What is NDC 0363-0858?
0363-0858 is the product NDC for Indoor Outdoor Allergy Relief (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by Walgreens. It has 9 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Indoor Outdoor Allergy Relief (Loratadine).
What is the active ingredient?
Loratadine.
Who is the labeler?
Walgreens, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Indoor Outdoor Allergy Relief?
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 075209

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

FDA NDC Directory listings under ANDA 075209
ProductStrengthForm · routeLabelerProduct NDC
All Day Allergy ReliefloratadineLoratadine 10 mg/1TabletOralSafeway, Inc.21130-914
All Day Allergy ReliefloratadineLoratadine 10 mg/1TabletOralFamily Dollar (FAMILY WELLNESS)55319-938
All Day Allergy ReliefloratadineLoratadine 10 mg/1TabletOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-718
All Day Allergy ReliefloratadineLoratadine 10 mg/1TabletOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-985
All Day Allergy ReliefloratadineLoratadine 10 mg/1TabletOralWALMART INC. (see also Equate)79903-156
All Day Allergy ReliefloratadineLoratadine 10 mg/1TabletOralWALMART INC. (see also Equate)79903-437
All Day Allergy ReliefloratadineLoratadine 10 mg/1TabletOralQUALITY CHOICE (Chain Drug Marketing Association)83324-146
All Day Allergy ReliefloratadineLoratadine 10 mg/1TabletOralQUALITY CHOICE (Chain Drug Marketing Association)83324-147
Allergy reliefloratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-6164
Allergy reliefloratadineLoratadine 10 mg/1TabletOralGeri-Care Pharmaceutical Corp57896-658
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralWinCo Foods, LLC67091-350
Allergy reliefloratadineLoratadine 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4016
Allergy reliefloratadineLoratadine 10 mg/1TabletOralBryant Ranch Prepack72162-2181
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralQUALITY CHOICE (Chain Drug Marketing Association)83324-150
ClaritinloratadineLoratadine 10 mg/1TabletOralBayer HealthCare LLC.11523-0007
ClaritinloratadineLoratadine 10 mg/1TabletOralBayer HealthCare LLC.11523-0800
Claritinloratadine tabletLoratadine 10 mg/1TabletOralLil' Drug Store Products, Inc.66715-9742
ClaritinloratadineLoratadine 10 mg/1TabletOralSelect Consumer Group85237-1630
CounterAct AllergyloratadineLoratadine 10 mg/1TabletOralMelaleuca, Inc.54473-166
LoratadineLoratadine 10 mg/1TabletOralPLD Acquisitions LLC DBA Avma Pharma Solutions63548-0753

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