Over-the-counter drug · ANDA
Leader Allergy Relief (Loratadine) NDC 70000-0213
Loratadine 10 mg/1 · Tablet · Oral · Cardinal Health 110, LLC. dba Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0213-1 | 70000021301 | 10 BLISTER PACK in 1 CARTON (70000-0213-1) / 1 TABLET in 1 BLISTER PACKMarketed from Dec 9, 2016 | |
| 70000-0213-3 | 70000021303 | 1 BOTTLE in 1 CARTON (70000-0213-3) / 70 TABLET in 1 BOTTLEMarketed from Dec 9, 2016 | |
| 70000-0213-4 | 70000021304 | 1 BOTTLE in 1 CARTON (70000-0213-4) / 90 TABLET in 1 BOTTLEMarketed from Dec 9, 2016 | |
| 70000-0213-6 | 70000021306 | 1 BOTTLE in 1 CARTON (70000-0213-6) / 300 TABLET in 1 BOTTLEMarketed from Jan 14, 2020 | |
| 70000-0213-7 | 70000021307 | 1 BOTTLE in 1 CARTON (70000-0213-7) / 100 TABLET in 1 BOTTLEMarketed from Apr 1, 2025 |
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)
- Leader Allergy Relief
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076301
- Marketing start
- Listing expires
- Identifiers
- Product ID 70000-0213_ef5ff212-8517-4598-9876-2ba32b9d360bSPL ID ef5ff212-8517-4598-9876-2ba32b9d360bSPL set ID 6f5134c6-ece6-4e35-a0c3-13e0dfa173faRxCUI 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
N470000021301followed by a unit qualifier and the quantityPackage 70000-0213-01. 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 70000-0213
- What is NDC 70000-0213?
- 70000-0213 is the product NDC for Leader Allergy Relief (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Leader Allergy Relief (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Leader Allergy Relief?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 | Walgreen Company | 0363-1612 |
| 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 |
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