Over-the-counter drug · ANDA
cetirizine hydrochloride NDC 59556-894
Cetirizine hydrochloride 10 mg/1 · Capsule, Liquid filled · Oral · Strides Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59556-894-12 | 59556089412 | 1 BOTTLE in 1 CARTON (59556-894-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Jul 21, 2017 | |
| 59556-894-77 | 59556089477 | 1 BOTTLE in 1 CARTON (59556-894-77) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Jul 21, 2017 | |
| 59556-894-78 | 59556089478 | 1 BOTTLE in 1 CARTON (59556-894-78) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Jul 21, 2017 | |
| 59556-894-79 | 59556089479 | 7000 CAPSULE, LIQUID FILLED in 1 BAG (59556-894-79)Marketed from Jul 21, 2017 |
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
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Strides Pharma, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205291
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 59556-894_59c7dbe5-bf71-fd55-e063-6294a90a7635SPL ID 59c7dbe5-bf71-fd55-e063-6294a90a7635SPL set ID 29c433eb-6cf4-4bcf-8b2a-0398fb4cdcbaRxCUI 1014675UNII 64O047KTOAUPC 0359556894770
- 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
N459556089412followed by a unit qualifier and the quantityPackage 59556-0894-12. 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.
Other NDCs under ANDA 205291
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 hcl | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | WALMART INC. (see also Equate) | 79903-344 |
| All Day Allergycetirizine hcl | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Care One (American Sales Company) | 41520-212 |