Over-the-counter drug · ANDA
Allergy (Loratadine) NDC 63654-309
Loratadine 10 mg/1 · Tablet · Oral · Selder, S.A. de C.V.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63654-309-10 | 6365403091063654030910 | 1 BLISTER PACK in 1 CARTON (63654-309-10) / 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
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Selder, S.A. de C.V.NDC labeler code 63654
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076471
- Marketing start
- Listing expires
- Identifiers
- Product ID 63654-309_39201d37-e750-420b-8035-feb97bc77c21SPL ID 39201d37-e750-420b-8035-feb97bc77c21SPL set ID afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251RxCUI 311372UNII 7AJO3BO7QNUPC 0645981000269
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
N463654030910followed by a unit qualifier and the quantityPackage 63654-0309-10. 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: ■ sneezing ■ runny nose ■ itchy, watery eyes ■ itching of the nose or throat.
Excerpt only. Read the full label for complete information.
About NDC 63654-309
- What is NDC 63654-309?
- 63654-309 is the product NDC for Allergy (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by Selder, S.A. de C.V.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Allergy (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Selder, S.A. de C.V., NDC labeler code 63654. 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?
- 25 other product NDCs are listed under this name. See all Allergy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Allergy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Allergymometasone furoate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | Amazon.com Services LLC | 72288-506 | 72288-0506-02 |
| Allergyfexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-716 | 72288-0716-0072288-0716-39 |
| allergymometasone furoate monohydrate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | HyVee Inc | 42507-182 | 42507-0182-02 |
| Allergydiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Publix Super Markets Inc | 56062-923 | 56062-0923-0856062-0923-12 |
| Allergymometasone furoate monohydrate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | Rite Aid Corporation | 11822-7099 | 11822-7099-01 |
| allergymometasone furoate monohydrate | Mometasone furoate monohydrate 50 ug/1 | Spray, MeteredNasal | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-117 | 51316-0117-11 |
| Allergyallium cepa, ambrosia, arsenicum alb, carbo veg, euphrasia, nux vom, phosphorus, pulsatilla, sulphur, solidago | Onion 30 [hp_C]/mL + 8 more ingredients | LiquidOral | Zorex International | 81825-0007 | 81825-0007-01 |
| Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Kroger Company | 41226-160 | 41226-0160-0141226-0160-4041226-0160-42 |
| Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Kroger Company | 41226-692 | 41226-0692-1441226-0692-6541226-0692-70 |
| Allergyallium sat, anacardium, apis mel, gambogia, merc solub, nat carb, nitricum ac, nux vom, phosphorus, pulsatilla, sulphur | Garlic 12 [hp_X]/59.1mL + 10 more ingredients | LiquidOral | Net Remedies | 61626-0109 | 61626-0109-04 |
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 |
|---|---|---|---|---|
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Allegiant Health | 69168-309 |
| Non-Drowsy Allergy Reliefloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 66715-8815 |