Over-the-counter drug · ANDA
Berkley and Jensen Allergy Relief (Loratadine) NDC 68391-314
Loratadine 10 mg/1 · Tablet · Oral · BJWC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68391-314-79 | 6839103147968391031479 | 2 BOTTLE in 1 PACKAGE (68391-314-79) / 200 TABLET in 1 BOTTLE (68391-314-82)Marketed from Sep 4, 2025 | |
| 68391-314-88 | 6839103148868391031488 | 1 BOTTLE in 1 PACKAGE (68391-314-88) / 365 TABLET in 1 BOTTLEMarketed from Sep 9, 2011 |
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)
- Berkley and Jensen Allergy Relief
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- BJWCNDC labeler code 68391
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076301
- Marketing start
- Listing expires
- Identifiers
- Product ID 68391-314_0b39c8ab-d1f9-422e-9c99-67cd2b6cab64SPL ID 0b39c8ab-d1f9-422e-9c99-67cd2b6cab64SPL set ID e981a0ef-08e9-4ac3-92a1-411217e0a251RxCUI 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
N468391031479followed by a unit qualifier and the quantityPackage 68391-0314-79. 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 68391-314
- What is NDC 68391-314?
- 68391-314 is the product NDC for Berkley and Jensen Allergy Relief, Loratadine 10 mg/1 tablet, listed with the FDA by BJWC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Berkley and Jensen Allergy Relief (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- BJWC, NDC labeler code 68391. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Berkley and Jensen Allergy Relief?
- 1 other product NDC are listed under this name. See all Berkley and Jensen 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 Berkley and Jensen 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) |
|---|---|---|---|---|---|
| Berkley and Jensen Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | BJWC | 68391-200 | 68391-0200-79 |
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 |
|---|---|---|---|---|
| equate allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Wal-Mart Stores Inc | 49035-612 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Proficient Rx LP | 63187-601 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7066 |
| TopCare Allergy Relief 24 hourloratadine | Loratadine 10 mg/1 | TabletOral | Topco Associates LLC | 36800-612 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-653 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | L. Perrigo Company | 0113-1612 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-0836 |
| allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Rite Aid Corporation | 11822-0612 |
| members mark allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Sam's West Inc | 68196-711 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | L. Perrigo Company | 0113-0612 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5532 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7158 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-423 |
| kirkland signature allerclearloratadine | Loratadine 10 mg/1 | TabletOral | Costco Wholesale Company | 63981-612 |
| foster and thrive allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-1022 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6852 |
| exchange select allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Army & Air Force Exchange Service | 55301-612 |
| allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Walgreen Company | 0363-1612 |
| allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | CVS Pharmacy | 59779-612 |
| allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Meijer Distribution Inc | 41250-612 |
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