Over-the-counter drug · ANDA
Cetirizine Hydrochloride Tablets,10 mg (Cetirizine hydrochloride) NDC 49483-692
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · TIME CAP LABORATORIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-692-01 | 4948306920149483069201 | 100 TABLET in 1 BOTTLE (49483-692-01)Marketed from Mar 11, 2024 | |
| 49483-692-20 | 4948306922049483069220 | 200 TABLET in 1 BOTTLE (49483-692-20)Marketed from Mar 11, 2024 | |
| 49483-692-50 | 4948306925049483069250 | 500 TABLET in 1 BOTTLE (49483-692-50)Marketed from May 30, 2022 | |
| 49483-692-65 | 4948306926549483069265 | 365 TABLET in 1 BOTTLE (49483-692-65)Marketed from Feb 12, 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)
- Cetirizine Hydrochloride Tablets,10 mg
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INC.NDC labeler code 49483
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078933
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 49483-692_12f9d89b-5334-1339-e063-6394a90ad0e8SPL ID 12f9d89b-5334-1339-e063-6394a90ad0e8SPL set ID d78223ba-80d5-47f8-e053-2a95a90aebdbRxCUI 1014678UNII 64O047KTOAUPC 0349483692501, 0349483692655, 0349483692013
- 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
N449483069201followed by a unit qualifier and the quantityPackage 49483-0692-01. 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)
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 49483-692
- What is NDC 49483-692?
- 49483-692 is the product NDC for Cetirizine Hydrochloride Tablets,10 mg, Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by TIME CAP LABORATORIES, INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine Hydrochloride Tablets,10 mg (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- TIME CAP LABORATORIES, INC., NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cetirizine Hydrochloride Tablets,10 mg?
- 2 other product NDCs are listed under this name. See all Cetirizine Hydrochloride Tablets,10 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cetirizine Hydrochloride Tablets,10 mg products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cetirizine Hydrochloride Tablets,10 mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-842 | 51655-0842-2651655-0842-5251655-0842-60+1 more |
| Cetirizine Hydrochloride Tablets, 10 mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-220 | 25000-0220-0325000-0220-0825000-0220-14+2 more |
Other NDCs under ANDA 078933
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 |
|---|---|---|---|---|
| All Day Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | DOLGENCORP, INC. | 55910-269 |
| Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Kroger Company | 41226-692 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | WALGREENS | 0363-1794 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | BETTER LIVING BRANDS, LLC | 21130-712 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-682 |
| Cetirizine Hydrochloride Tablets, 10 mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-220 |
| Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-160 |
| Cetirizine Hydrochloride Tablets, 5 mgcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-219 |
| Cetirizine Hydrochloride Tablets,10 mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-842 |