Over-the-counter drug · ANDA
Loratadine NDC 51316-502
Loratadine 5 mg/1 · Tablet, Orally disintegrating · Oral · CVS PHARMACY, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-502-01 | 51316050201 | 1 BLISTER PACK in 1 CARTON (51316-502-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 31, 2021 | |
| 51316-502-02 | 51316050202 | 2 BLISTER PACK in 1 CARTON (51316-502-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 31, 2021 | |
| 51316-502-03 | 51316050203 | 3 BLISTER PACK in 1 CARTON (51316-502-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 31, 2021 | |
| 51316-502-04 | 51316050204 | 4 BLISTER PACK in 1 CARTON (51316-502-04) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 31, 2021 | |
| 51316-502-05 | 51316050205 | 5 BLISTER PACK in 1 CARTON (51316-502-05) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 31, 2021 | |
| 51316-502-06 | 51316050206 | 6 BLISTER PACK in 1 CARTON (51316-502-06) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 31, 2021 |
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
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- CVS PHARMACY, INC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212795
- Marketing start
- Listing expires
- Identifiers
- Product ID 51316-502_28e49606-cbf6-7029-e063-6394a90ae3b7SPL ID 28e49606-cbf6-7029-e063-6394a90ae3b7SPL set ID 4e74e322-7f6e-467c-96c0-9b531ddb429bRxCUI 672558UNII 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
N451316050201followed by a unit qualifier and the quantityPackage 51316-0502-01. 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.
Other NDCs under ANDA 212795
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 |
|---|---|---|---|---|
| Allervarxloratadine | Loratadine 5 mg/1 | Tablet, Orally disintegratingOral | Innovus Pharmaceuticals, Inc. | 57483-955 |
| Loratadine | Loratadine 5 mg/1 | TabletOral | Tenshi Kaizen Pvt Ltd | 72983-500 |
| Loratadine | Loratadine 5 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 43598-756 |
| Loratadine | Loratadine 5 mg/1 | TabletOral | Walgreens Company | 0363-9955 |
| Loratadine | Loratadine 5 mg/1 | TabletOral | Strides Pharma Inc | 59556-301 |