Over-the-counter drug · ANDA
topcare all day allergy (Cetirizine hydrochloride) NDC 36800-448
Cetirizine hydrochloride 10 mg/1 · Capsule, Liquid filled · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-448-09 | 3680004480936800044809 | 1 BOTTLE in 1 PACKAGE (36800-448-09) / 65 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Feb 28, 2022 | |
| 36800-448-49 | 3680004484936800044849 | 1 BOTTLE in 1 PACKAGE (36800-448-49) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Feb 3, 2023 | |
| 36800-448-63 | 3680004486336800044863 | 1 BOTTLE in 1 PACKAGE (36800-448-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Feb 28, 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)
- topcare 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 213105
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 36800-448_eb748140-aec8-4fcf-9597-20610d87635aSPL ID eb748140-aec8-4fcf-9597-20610d87635aSPL set ID 10c512a1-bb96-4d2a-9e41-a422efb57e28RxCUI 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
N436800044809followed by a unit qualifier and the quantityPackage 36800-0448-09. 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 36800-448
- What is NDC 36800-448?
- 36800-448 is the product NDC for topcare all day allergy (cetirizine hydrochloride), Cetirizine hydrochloride 10 mg/1 capsule, liquid filled, listed with the FDA by Topco Associates LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- topcare 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 topcare all day allergy?
- 2 other product NDCs are listed under this name. See all topcare all day allergy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other topcare all day allergy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Topcare All Day Allergylevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-241 | 36800-0241-0136800-0241-4636800-0241-95 |
| TopCare All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-458 | 36800-0458-3936800-0458-4736800-0458-66+4 more |
Other NDCs under ANDA 213105
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 Allergycetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | WALMART INC. (see also Equate) | 79903-084 |
| All Day Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | P & L Development, LLC | 59726-064 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Safeway, Inc. | 21130-364 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | H E B | 37808-564 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | CVS PHARMACY, INC | 51316-064 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | CVS PHARMACY, INC | 51316-810 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | CVS PHARMACY, INC | 51316-811 |
| allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Publix Super Markets Inc | 56062-111 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Care One (Retail Business Services, LLC.) | 72476-064 |
| Allergy Reliefcetirizine hcl | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | WALMART INC. (see also Equate) | 79903-347 |
| basic care all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-980 |
| careone allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Retail Business Services, LLC | 72476-623 |
| dg health all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Dolgencorp Inc | 55910-934 |
| Good Sense All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | L. Perrigo Company | 0113-0981 |
| ZYRTEC Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Capsule, Liquid filledOral | Kenvue Brands LLC | 50580-786 |
| Zyrtec Allergy Cetirizine HClcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Jones Healthcare Group - Packaging Services, Inc | 67414-012 |
| Zyrtec Allergy Cetirizine HClcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | CapsuleOral | Jones Healthcare Group - Packaging Services, Inc | 67414-013 |