Over-the-counter drug · ANDA
Wal-Itin (Loratadine) NDC 0363-1686
Loratadine 10 mg/1 · Capsule, Liquid filled · Oral · WALGREENS
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-1686-07 | 0036316860700363168607 | 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0363-1686-07)Marketed from Oct 21, 2016 | |
| 0363-1686-30 | 0036316863000363168630 | 3 BLISTER PACK in 1 CARTON (0363-1686-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Oct 21, 2016 |
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)
- Wal-Itin
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- WALGREENSNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206214
- Marketing start
- Listing expires
- Identifiers
- Product ID 0363-1686_ed2fd264-8dba-e36d-e053-2a95a90aa08aSPL ID ed2fd264-8dba-e36d-e053-2a95a90aa08aSPL set ID 9e155aae-4735-4aab-bda9-c21ea29529a4RxCUI 828269, 1862280UNII 7AJO3BO7QNUPC 0311917185422
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
N400363168607followed by a unit qualifier and the quantityPackage 00363-1686-07. 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)
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 0363-1686
- What is NDC 0363-1686?
- 0363-1686 is the product NDC for Wal-Itin (loratadine), Loratadine 10 mg/1 capsule, liquid filled, listed with the FDA by WALGREENS. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Wal-Itin (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 Wal-Itin?
- 3 other product NDCs are listed under this name. See all Wal-Itin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Wal-Itin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Wal-itinloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | WALGREENS CO. | 0363-9995 | 00363-9995-30 |
| Wal-itinloratadine | Loratadine 10 mg/1 | TabletOral | Walgreens | 0363-9150 | 00363-9150-0300363-9150-0500363-9150-10+7 more |
| Wal-itinloratadine | Loratadine 5 mg/1 | Tablet, ChewableOral | Walgreens | 0363-0754 | 00363-0754-30 |
Other NDCs under ANDA 206214
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 |
|---|---|---|---|---|
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | TARGET CORPORATION | 11673-986 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | Safeway | 21130-195 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0755 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-103 |
| Loratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | MARKSANS PHARMA LIMITED | 25000-021 |
| Loratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | KROGER COMPANY | 41226-686 |
| Loratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES INC | 49483-686 |
| Loratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | SMART SENSE (KMART) | 49738-686 |
| Loratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | CVS HEALTH CORP | 69842-686 |