Over-the-counter drug · ANDA
Allergy Relief (Loratadine) NDC 69168-309
Loratadine 10 mg/1 · Tablet · Oral · Allegiant Health
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69168-309-03 | 69168030903 | 30 TABLET in 1 BLISTER PACK (69168-309-03)Marketed from Dec 16, 2014 | |
| 69168-309-08 | 69168030908 | 1 BLISTER PACK in 1 CARTON (69168-309-08) / 5 TABLET in 1 BLISTER PACKMarketed from Dec 16, 2014 | |
| 69168-309-09 | 69168030909 | 1 BLISTER PACK in 1 CARTON (69168-309-09) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 16, 2014 |
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)
- Allergy Relief
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Allegiant HealthNDC labeler code 69168
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076471
- Marketing start
- Listing expires
- Identifiers
- Product ID 69168-309_520a7a7c-a1a5-48a6-b472-9d47a4463452SPL ID 520a7a7c-a1a5-48a6-b472-9d47a4463452SPL set ID 0991388a-2eb8-4913-9efc-adf411eddf3aRxCUI 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
N469168030903followed by a unit qualifier and the quantityPackage 69168-0309-03. 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 69168-309
- What is NDC 69168-309?
- 69168-309 is the product NDC for Allergy Relief (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by Allegiant Health. It has 3 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?
- Allegiant Health, NDC labeler code 69168. 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 076471
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 |
|---|---|---|---|---|
| Allergyloratadine | Loratadine 10 mg/1 | TabletOral | Selder, S.A. de C.V. | 63654-309 |
| Non-Drowsy Allergy Reliefloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 66715-8815 |