Over-the-counter drug · ANDA

topcare allergy relief (Fexofenadine hydrochloride) NDC 36800-691

Fexofenadine hydrochloride 180 mg/1 · Tablet, Film coated · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-691Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0691Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
36800-691-3936800069139368000691391 BOTTLE in 1 CARTON (36800-691-39) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 23, 2021
36800-691-4936800069149368000691491 BOTTLE in 1 CARTON (36800-691-49) / 40 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 21, 2021
36800-691-7536800069175368000691751 BOTTLE in 1 CARTON (36800-691-75) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 21, 2021

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 allergy relief
Generic name (nonproprietary)
fexofenadine hydrochloride
Active ingredients
Fexofenadine hydrochloride — 180 mg/1
Dosage form
Tablet, Film coated
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 212971
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 36800-691_9cb64047-5e7e-4fbc-913a-e3831cf557f4SPL ID 9cb64047-5e7e-4fbc-913a-e3831cf557f4SPL set ID e7658b5f-2d78-4f25-b1a3-e49198ca8f32RxCUI 997420UNII 2S068B75ZU
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

N436800069139 followed by a unit qualifier and the quantity

Package 36800-0691-39. 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 • itchy, watery eyes • sneezing • itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 36800-691

What is NDC 36800-691?
36800-691 is the product NDC for topcare allergy relief (fexofenadine hydrochloride), Fexofenadine hydrochloride 180 mg/1 tablet, film coated, 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 allergy relief (Fexofenadine hydrochloride).
What is the active ingredient?
Fexofenadine 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 allergy relief?
3 other product NDCs are listed under this name. See all topcare allergy relief NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other topcare allergy relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TopCare Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralTOPCO ASSOCIATES LLC36800-36736800-0367-24
topcare allergy reliefloratadineLoratadine 10 mg/1Capsule, Liquid filledOralTopco Associates LLC36800-75536800-0755-3936800-0755-52
Topcare Allergy ReliefloratadineLoratadine 10 mg/1Tablet, Orally disintegratingOralTopco Associates LLC36800-85336800-0853-65

Other NDCs under ANDA 212971

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212971
ProductStrengthForm · routeLabelerProduct NDC
Allergyfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-716
Leader 24HR Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. dba Leader70000-0725
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralWalgreen Company0363-1847
careone allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralRetail Business Services, LLC72476-847
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralPadagis Israel Pharmaceuticals Ltd45802-847
Fexofenadine HydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralProficient Rx LP71205-739
allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralHyVee Inc42507-847
allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-847
basic care allergyfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-847
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralKroger Company30142-856
good sense aller easefexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralL. Perrigo Company0113-0847
berkley jensen allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralBJWC68391-847
Basic Care Allergyfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-722
up and up non drowsy allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralTarget Corporation82442-300
Hives Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralWalgreen Company0363-4071
kirkland signature aller fexfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralCostco Wholesale Company63981-847
Allergy Relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralCVS Pharmacy69842-914
allergy relieffexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralWalgreen Company0363-7011
Basic Care Allergyfexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, CoatedOralAmazon.com Services LLC72288-537
exchange select aller easefexofenadine hydrochlorideFexofenadine hydrochloride 180 mg/1Tablet, Film coatedOralArmy & Air Force Exchange Service55301-847

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