Over-the-counter drug · ANDA
allergy relief (Cetirizine hydrochloride) NDC 37808-583
Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · H E B
NDC codes
FDA NDC DirectoryProduct NDC (as listed)37808-583Labeler and product segments. Claims need a package NDC.
Product NDC at billing width37808-0583Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 37808-583-06 | 37808058306 | 1 BOTTLE in 1 CARTON (37808-583-06) / 70 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 26, 2018 | |
| 37808-583-39 | 37808058339 | 1 BOTTLE in 1 CARTON (37808-583-39) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 26, 2018 | |
| 37808-583-66 | 37808058366 | 14 BLISTER PACK in 1 CARTON (37808-583-66) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 26, 2018 | |
| 37808-583-76 | 37808058376 | 1 BOTTLE in 1 CARTON (37808-583-76) / 120 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 26, 2018 | |
| 37808-583-87 | 37808058387 | 1 BOTTLE in 1 CARTON (37808-583-87) / 300 TABLET, FILM COATED in 1 BOTTLE (37808-583-00)Marketed from Jun 19, 2026 |
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)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- H E BNDC labeler code 37808
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078336
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 37808-583_e2ba6632-3350-4d5f-a03e-5e68dce98576SPL ID e2ba6632-3350-4d5f-a03e-5e68dce98576SPL set ID 8649fc1e-ad56-4660-bbbb-8f1ed795697bRxCUI 1014678UNII 64O047KTOA
- 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
N437808058306followed by a unit qualifier and the quantityPackage 37808-0583-06. 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 • sneezing • itchy, watery eyes • itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 37808-583
- What is NDC 37808-583?
- 37808-583 is the product NDC for allergy relief (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by H E B. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- allergy relief (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- H E B, NDC labeler code 37808. 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?
- 263 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 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 |
| Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | P & L Development, LLC | 59726-203 | 59726-0203-3859726-0203-54 |
Other NDCs under ANDA 078336
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 |
|---|---|---|---|---|
| 24 hour allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-458 |
| all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-1002 |
| All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | HyVee Inc | 42507-458 |
| allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-4101 |
| allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Safeway | 21130-425 |
| Allergy Relief Indoor and Outdoor Allergiescetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 59779-458 |
| basic care all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-411 |
| Berkley And Jensen All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | BJWC | 68391-400 |
| betr remedies all day allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Live Betr LLC | 80267-409 |
| CareOne Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-781 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6717 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7510 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5510 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7594 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-194 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0194 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-123 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2162 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | VERITYRX, LLC | 83939-0003 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-919 |
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