Over-the-counter drug · ANDA
top care all day allergy (Cetirizine hydrochloride) NDC 36800-180
Cetirizine hydrochloride 10 mg/1 · Capsule, Liquid filled · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-180-09 | 3680001800936800018009 | 1 BOTTLE in 1 PACKAGE (36800-180-09) / 65 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Jun 8, 2020 | |
| 36800-180-63 | 3680001806336800018063 | 1 BOTTLE in 1 PACKAGE (36800-180-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Jun 6, 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)
- top care all day allergy
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207235
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 36800-180_6fe07c0a-a5f6-45dd-b67e-ea214d3870e3SPL ID 6fe07c0a-a5f6-45dd-b67e-ea214d3870e3SPL set ID 1a217b8a-621a-4b6d-a7ed-37b04f829d66RxCUI 1014675UNII 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
N436800018009followed by a unit qualifier and the quantityPackage 36800-0180-09. 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 36800-180
- What is NDC 36800-180?
- 36800-180 is the product NDC for top care all day allergy (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 capsule, liquid filled, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- top care all day allergy (Cetirizine hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for top care all day allergy?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 207235
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 | Capsule, Liquid filledOral | Meijer Distribution Inc | 41250-618 |
| All Day Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | P & L Development, LLC | 59726-741 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-841 |
| basic care all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-007 |
| CareOne Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | American Sales Company | 41520-715 |
| dg health all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Dolgencorp, LLC | 55910-710 |