Over-the-counter drug · ANDA
good sense allergy relief (Loratadine) NDC 0113-1612
Loratadine 10 mg/1 · Tablet · Oral · L. Perrigo Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0113-1612-95 | 0011316129500113161295 | 1 BOTTLE in 1 CARTON (0113-1612-95) / 45 TABLET in 1 BOTTLEMarketed from Sep 26, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- good sense allergy relief
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- L. Perrigo CompanyNDC labeler code 0113
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076301
- Marketing start
- Listing expires
- Identifiers
- Product ID 0113-1612_bf838a8e-a12d-4970-8613-56a8b1864f33SPL ID bf838a8e-a12d-4970-8613-56a8b1864f33SPL set ID 74bed4ad-5afe-4293-bef3-e0b9d5f64a29RxCUI 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
N400113161295followed by a unit qualifier and the quantityPackage 00113-1612-95. 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 0113-1612
- What is NDC 0113-1612?
- 0113-1612 is the product NDC for good sense allergy relief (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by L. Perrigo Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- good sense allergy relief (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- L. Perrigo Company, NDC labeler code 0113. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for good sense allergy relief?
- 7 other product NDCs are listed under this name. See all good sense 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 good sense 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) |
|---|---|---|---|---|---|
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | L. Perrigo Company | 0113-9755 | 00113-9755-65 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | L. Perrigo Company | 0113-1191 | 00113-1191-65 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | L. Perrigo Company | 0113-0612 | 00113-0612-4600113-0612-6500113-0612-75+3 more |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7048 | 50090-7048-0050090-7048-0450090-7048-05 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7049 | 50090-7049-04 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7051 | 50090-7051-00 |
| good sense allergy reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | L. Perrigo Company | 0113-0479 | 00113-0479-6200113-0479-7800113-0479-79 |
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 |
|---|---|---|---|---|
| goodnow allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Gobrands, Inc | 82501-0612 |
| CareOne Allergy Relief 24 Hourloratadine | Loratadine 10 mg/1 | TabletOral | American Sales Company | 41520-612 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Kroger Company | 30142-612 |
| Leader Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Cardinal Health 110, LLC. dba Leader | 70000-0213 |
| good neighbor pharmacy loratadineloratadine | Loratadine 10 mg/1 | TabletOral | Amerisource Bergen | 24385-471 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6852 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Padagis Israel Pharmaceuticals Ltd | 45802-650 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-347 |
| up and up allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Target Corporation | 11673-612 |
| dg health allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dolgencorp Inc | 55910-806 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-380 |
| 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 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Proficient Rx LP | 63187-601 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-259 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8217 |
| equate allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Wal-Mart Stores Inc | 49035-612 |
| TopCare Allergy Relief 24 hourloratadine | Loratadine 10 mg/1 | TabletOral | Topco Associates LLC | 36800-612 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7066 |
Showing 20 of 39.