Over-the-counter drug · ANDA
Allergy Relief NDC 53942-396
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · Demoulas Super Markets, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)53942-396Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53942-0396Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53942-396-01 | 5394203960153942039601 | 1 BOTTLE in 1 CARTON (53942-396-01) / 100 TABLET in 1 BOTTLEMarketed from Nov 30, 2020 | |
| 53942-396-10 | 5394203961053942039610 | 1 BLISTER PACK in 1 CARTON (53942-396-10) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 30, 2018 | |
| 53942-396-30 | 5394203963053942039630 | 1 BOTTLE in 1 CARTON (53942-396-30) / 30 TABLET in 1 BOTTLEMarketed from Nov 30, 2020 |
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 Relief
- Generic name (nonproprietary)
- allergy relief
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Demoulas Super Markets, Inc.NDC labeler code 53942
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209274
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 53942-396_250f1234-a789-4c14-92c0-e80dace6b3bbSPL ID 250f1234-a789-4c14-92c0-e80dace6b3bbSPL set ID 2fba5fb9-5967-4136-a4c3-31a67b81265bUNII 64O047KTOAUPC 0049705842997
- Pharmacologic class
- Histamine-1 Receptor Antagonist
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
N453942039601followed by a unit qualifier and the quantityPackage 53942-0396-01. 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)
Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 53942-396
- What is NDC 53942-396?
- 53942-396 is the product NDC for Allergy Relief, Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by Demoulas Super Markets, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Allergy Relief.
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Demoulas Super Markets, Inc., NDC labeler code 53942. 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 Relief?
- 271 other product NDCs are listed under this name. See all 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 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) |
|---|---|---|---|---|---|
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Famora Inc. | 87509-0003 | 87509-0003-06 |
| Allergy Relieflevocetirizine dihydrochloride usp, 5 mg | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Topco Associates, LLC | 76162-915 | 76162-0915-3576162-0915-80 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-391 | 72288-0391-0172288-0391-78 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0771 | 70000-0771-0170000-0771-02 |
| Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-784 | 72288-0784-27 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Meijer, Inc. | 79481-9723 | 79481-9723-01 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 75907-434 | 75907-0434-0175907-0434-30 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | Kroger Company | 30142-856 | 30142-0856-62 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | NUVICARE LLC | 84324-040 | 84324-0040-01 |
| Allergy Reliefcetirizine tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | DISCOUNT DRUG MART, INC | 53943-130 | 53943-0130-1353943-0130-17 |
Other NDCs under ANDA 209274
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 Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Grocery Outlet, Inc | 85828-194 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | AAA PHARMACEUTICAL, INC. | 57344-194 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Bi-Mar | 37835-611 |
| All Day Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-0057 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | LIDL US LLC | 71141-294 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-091 |
| Cetirizinecetiirizine | Cetirizine hydrochloride 10 mg/1 | TabletOral | CVS PHARMACY, INC | 51316-764 |
| Crcle Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Innovus Pharmaceuticals, Inc. | 57483-250 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Advanced Rx LLC | 80513-731 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Granules Pharmaceuticals Inc. | 70010-163 |
| ValuMeds 24-Hour Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1003 |
| CABINET Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-0119 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9733 |
| ValuMeds Cetirizine 10mgcetirizine 10mg | Cetirizine hydrochloride 10 mg/1 | TabletOral | Cabinet Health | 82725-1203 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | CVS PHARMACY, INC | 51316-806 |
| Cetirizine Hydrochloride 10 Mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | YYBA CORP | 73581-202 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Granules India Ltd | 62207-764 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-4230 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-4219 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-1047 |
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