Over-the-counter drug · ANDA
Loratadine Allergy Relief (Loratadine) NDC 71335-0100
Loratadine 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC DirectoryProduct NDC (as listed)71335-0100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0100Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0100-1 | 71335010001 | 20 TABLET in 1 BOTTLE (71335-0100-1)Marketed from Feb 12, 2018 | |
| 71335-0100-2 | 71335010002 | 30 TABLET in 1 BOTTLE (71335-0100-2)Marketed from Feb 23, 2018 | |
| 71335-0100-3 | 71335010003 | 60 TABLET in 1 BOTTLE (71335-0100-3)Marketed from Dec 27, 2021 | |
| 71335-0100-4 | 71335010004 | 14 TABLET in 1 BOTTLE (71335-0100-4)Marketed from Dec 27, 2021 | |
| 71335-0100-5 | 71335010005 | 10 TABLET in 1 BOTTLE (71335-0100-5)Marketed from Feb 20, 2018 | |
| 71335-0100-6 | 71335010006 | 90 TABLET in 1 BOTTLE (71335-0100-6)Marketed from Feb 9, 2018 | |
| 71335-0100-7 | 71335010007 | 28 TABLET in 1 BOTTLE (71335-0100-7)Marketed from Apr 5, 2024 | |
| 71335-0100-8 | 71335010008 | 15 TABLET in 1 BOTTLE (71335-0100-8)Marketed from Apr 5, 2024 | |
| 71335-0100-9 | 71335010009 | 100 TABLET in 1 BOTTLE (71335-0100-9)Marketed from Apr 5, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076134
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-0100_ca06cd0b-6979-4948-91c4-8635aec581c9SPL ID ca06cd0b-6979-4948-91c4-8635aec581c9SPL set ID 40914eeb-3a85-4691-9fb8-2df72ba1f709RxCUI 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
N471335010001followed by a unit qualifier and the quantityPackage 71335-0100-01. 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 71335-0100
- What is NDC 71335-0100?
- 71335-0100 is the product NDC for Loratadine Allergy Relief (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 9 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 | Asclemed USA, Inc. | 76420-330 | 76420-0330-0176420-0330-0376420-0330-05+7 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 | Proficient Rx LP | 63187-100 |
| 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 |
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