Over-the-counter drug · ANDA
Indoor Outdoor Allergy Relief (Loratadine) NDC 0363-0858
Loratadine 10 mg/1 · Tablet · Oral · Walgreens
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0858-03 | 0036308580300363085803 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0858-03) / 30 TABLET in 1 BOTTLE, PLASTICMarketed from Sep 30, 2018 | |
| 0363-0858-05 | 0036308580500363085805 | 5 BLISTER PACK in 1 CARTON (0363-0858-05) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 30, 2018 | |
| 0363-0858-10 | 0036308581000363085810 | 10 BLISTER PACK in 1 CARTON (0363-0858-10) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 30, 2018 | |
| 0363-0858-15 | 0036308581500363085815 | 1 BOTTLE, PLASTIC in 1 CARTON (0363-0858-15) / 150 TABLET in 1 BOTTLE, PLASTICMarketed from Sep 30, 2018 | |
| 0363-0858-20 | 0036308582000363085820 | 20 BLISTER PACK in 1 CARTON (0363-0858-20) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 30, 2018 | |
| 0363-0858-30 | 0036308583000363085830 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0858-30) / 300 TABLET in 1 BOTTLE, PLASTICMarketed from Sep 30, 2018 | |
| 0363-0858-45 | 0036308584500363085845 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0858-45) / 45 TABLET in 1 BOTTLE, PLASTICMarketed from Sep 30, 2018 | |
| 0363-0858-70 | 0036308587000363085870 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0858-70) / 70 TABLET in 1 BOTTLE, PLASTICMarketed from Sep 30, 2018 | |
| 0363-0858-90 | 0036308589000363085890 | 1 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
N400363085803followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Safeway, Inc. | 21130-914 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Family Dollar (FAMILY WELLNESS) | 55319-938 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-718 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-985 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WALMART INC. (see also Equate) | 79903-156 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WALMART INC. (see also Equate) | 79903-437 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-146 |
| All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-147 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6164 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Geri-Care Pharmaceutical Corp | 57896-658 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WinCo Foods, LLC | 67091-350 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4016 |
| Allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2181 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-150 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Bayer HealthCare LLC. | 11523-0007 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Bayer HealthCare LLC. | 11523-0800 |
| Claritinloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 66715-9742 |
| Claritinloratadine | Loratadine 10 mg/1 | TabletOral | Select Consumer Group | 85237-1630 |
| CounterAct Allergyloratadine | Loratadine 10 mg/1 | TabletOral | Melaleuca, Inc. | 54473-166 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0753 |
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