Over-the-counter drug · ANDA
signature care allergy relief (Loratadine) NDC 21130-452
Loratadine 10 mg/1 · Tablet, Orally disintegrating · Oral · Safeway
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-452-65 | 2113004526521130045265 | 30 BLISTER PACK in 1 CARTON (21130-452-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Mar 29, 2022 |
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)
- signature care allergy relief
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- SafewayNDC labeler code 21130
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076011
- Marketing start
- Listing expires
- Identifiers
- Product ID 21130-452_62dd431d-c820-4611-803a-720b4dbf720dSPL ID 62dd431d-c820-4611-803a-720b4dbf720dSPL set ID 0a4b8eef-762e-42cc-84ee-0018a9a3be58RxCUI 311373UNII 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
N421130045265followed by a unit qualifier and the quantityPackage 21130-0452-65. 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 21130-452
- What is NDC 21130-452?
- 21130-452 is the product NDC for signature care allergy relief (loratadine), Loratadine 10 mg/1 tablet, orally disintegrating, listed with the FDA by Safeway. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- signature care allergy relief (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Safeway, NDC labeler code 21130. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for signature care allergy relief?
- 1 other product NDC are listed under this name. See all signature care 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 signature care 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) |
|---|---|---|---|---|---|
| signature care allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Safeway | 21130-090 | 21130-0090-95 |
Other NDCs under ANDA 076011
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 | Tablet, Orally disintegratingOral | Kroger Company | 30142-446 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-931 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Meijer, Inc. | 79481-9723 |
| Basic Care Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Amazon.com Services LLC | 72288-200 |
| Basic Care Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Amazon.com Services LLC | 72288-451 |
| careone allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | American Sales Company | 41520-510 |
| dg health allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Dolgencorp, LLC | 55910-594 |
| dg health allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Dolgencorp, LLC | 55910-970 |
| equate loratadineloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | WALMART INC. | 79903-381 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | L. Perrigo Company | 0113-1191 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | L. Perrigo Company | 0113-9755 |
| loratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Rite Aid Corporation | 11822-0558 |
| non drowsy allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Meijer Distribution Inc | 41250-890 |
| Topcare Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Topco Associates LLC | 36800-853 |