Over-the-counter drug · ANDA
Loratadine Allergy Relief (Loratadine) NDC 63187-100
Loratadine 10 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC DirectoryProduct NDC (as listed)63187-100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0100Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-100-10 | 63187010010 | 10 TABLET in 1 BOTTLE (63187-100-10)Marketed from Jan 1, 2019 | |
| 63187-100-20 | 63187010020 | 20 TABLET in 1 BOTTLE (63187-100-20)Marketed from Jan 1, 2019 | |
| 63187-100-30 | 63187010030 | 30 TABLET in 1 BOTTLE (63187-100-30)Marketed from Jan 1, 2019 | |
| 63187-100-90 | 63187010090 | 90 TABLET in 1 BOTTLE (63187-100-90)Marketed from Oct 10, 2024 |
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 Allergy Relief
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076134
- Marketing start
- Listing expires
- Identifiers
- Product ID 63187-100_91a17d89-5112-4176-bfa0-9fd2d27922c5SPL ID 91a17d89-5112-4176-bfa0-9fd2d27922c5SPL set ID a6b9a1bf-1013-4a15-b3b2-a226a75a1ffbRxCUI 311372UNII 7AJO3BO7QNUPC 0363187100100
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
N463187010010followed by a unit qualifier and the quantityPackage 63187-0100-10. 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)
USE(S) 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 63187-100
- What is NDC 63187-100?
- 63187-100 is the product NDC for Loratadine Allergy Relief (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loratadine Allergy Relief (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. 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 Allergy Relief?
- 14 other product NDCs are listed under this name. See all Loratadine 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 Loratadine 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) |
|---|---|---|---|---|---|
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-763 | 10135-0763-0310135-0763-3010135-0763-90 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7507 | 50090-7507-0050090-7507-0450090-7507-05 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7508 | 50090-7508-04 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | HEB | 37808-529 | 37808-0529-0137808-0529-1137808-0529-31 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-2387 | 50090-2387-00 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | OHM LABORATORIES INC. | 51660-526 | 51660-0526-0151660-0526-0551660-0526-11+3 more |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | DISCOUNT DRUG MART | 53943-975 | 53943-0975-3053943-0975-60 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-728 | 55289-0728-1555289-0728-2055289-0728-60+1 more |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7772 | 63629-7772-0163629-7772-0263629-7772-03+6 more |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0100 | 71335-0100-0171335-0100-0271335-0100-03+6 more |
Other NDCs under ANDA 076134
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 |
|---|---|---|---|---|
| Green Guard 24 Hour Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-118 |
| Handy Solutions 24 Hour Allergyloratadine | Loratadine 10 mg/1 | Tablet, Film coatedOral | Navajo Manufacturing Company Inc. | 67751-163 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | SAFEWAY INC. | 21130-526 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4976 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | CVS Pharmacy | 59779-528 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Chain Drug Marketing Association Inc. | 63868-151 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Valu Merchandisers Company | 63941-526 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Premier Value | 68016-526 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | American Health Packaging | 68084-248 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-763 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | HEB | 37808-529 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-2387 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7507 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7508 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | OHM LABORATORIES INC. | 51660-526 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | DISCOUNT DRUG MART | 53943-975 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-728 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7772 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WinCo Foods, LLC | 67091-245 |
| Loratadine Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WinCo Foods, LLC | 67091-246 |
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