Over-the-counter drug · ANDA
allergy relief (Loratadine) NDC 0363-1612
Loratadine 10 mg/1 · Tablet · Oral · Walgreen Company
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0363-1612Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-1612Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-1612-03 | 00363161203 | 1 BOTTLE in 1 CARTON (0363-1612-03) / 70 TABLET in 1 BOTTLEMarketed from Apr 4, 2022 | |
| 0363-1612-47 | 00363161247 | 1 BOTTLE in 1 CARTON (0363-1612-47) / 150 TABLET in 1 BOTTLEMarketed from Oct 21, 2021 | |
| 0363-1612-58 | 00363161258 | 1 BOTTLE in 1 CARTON (0363-1612-58) / 40 TABLET in 1 BOTTLEMarketed from Dec 10, 2024 | |
| 0363-1612-65 | 00363161265 | 1 BOTTLE in 1 CARTON (0363-1612-65) / 30 TABLET in 1 BOTTLEMarketed from Oct 21, 2021 | |
| 0363-1612-78 | 00363161278 | 1 BOTTLE in 1 CARTON (0363-1612-78) / 100 TABLET in 1 BOTTLEMarketed from Dec 10, 2024 | |
| 0363-1612-88 | 00363161288 | 1 BOTTLE in 1 CARTON (0363-1612-88) / 365 TABLET in 1 BOTTLEMarketed from Mar 8, 2022 | |
| 0363-1612-95 | 00363161295 | 1 BOTTLE in 1 CARTON (0363-1612-95) / 45 TABLET in 1 BOTTLEMarketed from Aug 23, 2024 |
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)
- allergy relief
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Walgreen CompanyNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076301
- Marketing start
- Listing expires
- Identifiers
- Product ID 0363-1612_eff828bf-472b-4f68-a285-a7952c1d4a56SPL ID eff828bf-472b-4f68-a285-a7952c1d4a56SPL set ID 41f8fc1d-2d14-48da-a233-23e9c11296d9RxCUI 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
N400363161203followed by a unit qualifier and the quantityPackage 00363-1612-03. 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 • itchy, watery eyes • sneezing • itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 0363-1612
- What is NDC 0363-1612?
- 0363-1612 is the product NDC for allergy relief (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by Walgreen Company. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- allergy relief (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Walgreen Company, 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 allergy relief?
- 263 other product NDCs are listed under this name. See all allergy relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other allergy relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Allergy Relieflevocetirizine dihydrochloride usp, 5 mg | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Topco Associates, LLC | 76162-915 | 76162-0915-3576162-0915-80 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-391 | 72288-0391-0172288-0391-78 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0771 | 70000-0771-0170000-0771-02 |
| Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-784 | 72288-0784-27 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Meijer, Inc. | 79481-9723 | 79481-9723-01 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 75907-434 | 75907-0434-0175907-0434-30 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | Kroger Company | 30142-856 | 30142-0856-62 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | NUVICARE LLC | 84324-040 | 84324-0040-01 |
| Allergy Reliefcetirizine tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | DISCOUNT DRUG MART, INC | 53943-130 | 53943-0130-1353943-0130-17 |
| Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | P & L Development, LLC | 59726-203 | 59726-0203-3859726-0203-54 |
Other NDCs under ANDA 076301
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 | TabletOral | Rite Aid Corporation | 11822-0612 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Kroger Company | 30142-612 |
| allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Meijer Distribution Inc | 41250-612 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | HyVee Inc | 42507-612 |
| allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | CVS Pharmacy | 59779-612 |
| basic care allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Amazon.com Services LLC | 72288-612 |
| Berkley and Jensen Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | BJWC | 68391-314 |
| CareOne Allergy Relief 24 Hourloratadine | Loratadine 10 mg/1 | TabletOral | American Sales Company | 41520-612 |
| dg health allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dolgencorp Inc | 55910-806 |
| equate allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Wal-Mart Stores Inc | 49035-612 |
| exchange select allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Army & Air Force Exchange Service | 55301-612 |
| foster and thrive allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-1022 |
| good neighbor pharmacy loratadineloratadine | Loratadine 10 mg/1 | TabletOral | Amerisource Bergen | 24385-471 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | L. Perrigo Company | 0113-0612 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | L. Perrigo Company | 0113-1612 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7048 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7049 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7051 |
| goodnow allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Gobrands, Inc | 82501-0612 |
| kirkland signature allerclearloratadine | Loratadine 10 mg/1 | TabletOral | Costco Wholesale Company | 63981-612 |
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