Over-the-counter drug · ANDA
Cetirizine Hydrochloride NDC 55111-699
Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Dr.Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-699-04 | 5511106990455111069904 | 1 BOTTLE in 1 CARTON (55111-699-04) / 120 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 11, 2008 | |
| 55111-699-15 | 5511106991555111069915 | 1 BLISTER PACK in 1 CARTON (55111-699-15) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 4, 2008 | |
| 55111-699-19 | 5511106991955111069919 | 1 BOTTLE in 1 CARTON (55111-699-19) / 175 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 15, 2008 | |
| 55111-699-30 | 5511106993055111069930 | 1 BOTTLE in 1 CARTON (55111-699-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 3, 2008 | |
| 55111-699-31 | 5511106993155111069931 | 1 BOTTLE in 1 CARTON (55111-699-31) / 300 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 27, 2016 | |
| 55111-699-45 | 5511106994555111069945 | 1 BOTTLE in 1 CARTON (55111-699-45) / 45 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 8, 2008 | |
| 55111-699-47 | 5511106994755111069947 | 2 BOTTLE in 1 CARTON (55111-699-47) / 175 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 3, 2008 | |
| 55111-699-51 | 5511106995155111069951 | 1 BOTTLE in 1 CARTON (55111-699-51) / 75 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 22, 2008 | |
| 55111-699-52 | 5511106995255111069952 | 1 BOTTLE in 1 CARTON (55111-699-52) / 14 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 6, 2010 | |
| 55111-699-60 | 5511106996055111069960 | 1 BOTTLE in 1 CARTON (55111-699-60) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 7, 2008 | |
| 55111-699-73 | 5511106997355111069973 | 1 BOTTLE in 1 CARTON (55111-699-73) / 365 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 6, 2010 | |
| 55111-699-74 | 5511106997455111069974 | 2 BLISTER PACK in 1 CARTON (55111-699-74) / 7 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 4, 2008 | |
| 55111-699-90 | 5511106999055111069990 | 90 TABLET, FILM COATED in 1 BOTTLE (55111-699-90)Marketed from Apr 8, 2008 |
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
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Dr.Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078343
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55111-699_000d3a47-3836-b678-9487-2bbc518cd57fSPL ID 000d3a47-3836-b678-9487-2bbc518cd57fSPL set ID de152651-bfcd-856a-8329-a2ac93a376bcRxCUI 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
N455111069904followed by a unit qualifier and the quantityPackage 55111-0699-04. 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 55111-699
- What is NDC 55111-699?
- 55111-699 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Dr.Reddy's Laboratories Limited. It has 13 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine Hydrochloride.
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Dr.Reddy's Laboratories Limited, NDC labeler code 55111. 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?
- 107 other product NDCs are listed under this name. See all Cetirizine Hydrochloride 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 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 | Cetirizine hydrochloride 5 mg/1 | TabletOral | First Nation Group, LLC | 81469-352 | 81469-0352-01 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | First Nation Group, LLC | 81469-353 | 81469-0353-0181469-0353-0381469-0353-05+1 more |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-017 | 48433-0017-20 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Advagen Pharma Ltd., | 72888-480 | 72888-0480-01 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4072 | 68788-4072-0368788-4072-0668788-4072-09 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Bionpharma Inc. | 69452-426 | 69452-0426-5569452-0426-88 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-357 | 57237-0357-1257237-0357-24 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-358 | 57237-0358-1257237-0358-24 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | BAJAJ MEDICAL, LLC | 61037-480 | 61037-0480-2261037-0480-2361037-0480-24+2 more |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | BAJAJ MEDICAL, LLC | 61037-480 | 61037-0480-0261037-0480-0361037-0480-04+2 more |
Other NDCs under ANDA 078343
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 |
|---|---|---|---|---|
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Discount Drug Mart, Inc | 53943-519 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | VERITYRX, LLC | 83939-0004 |
| cetirizine hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services LLC | 70677-1007 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-045 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Limited | 55111-351 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-183 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-811 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-709 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9612 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-801 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8435 |