What is NDC 36800-050?

36800-050 is the product NDC for Topcare Ibuprofen PM, Diphenhydramine citrate 38 mg/1; Ibuprofen 200 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 Ibuprofen PM (Diphenhydramine citrate and ibuprofen).

What is the active ingredient?

Diphenhydramine citrate, Ibuprofen.

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 Ibuprofen PM?

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.

Topcare Ibuprofen PM NDC 36800-050

NDC codes

FDA NDC Directory

Product NDC (as listed)36800-050Labeler and product segments. Claims need a package NDC.

Product NDC at billing width36800-0050Add 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 NDC	11-digit (billing)	Package
36800-050-27	3680000502736800005027	1 BOTTLE in 1 CARTON (36800-050-27) / 80 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 24, 2009
36800-050-58	3680000505836800005058	1 BOTTLE in 1 CARTON (36800-050-58) / 40 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 18, 2009
36800-050-60	3680000506036800005060	1 BOTTLE in 1 CARTON (36800-050-60) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 19, 2009

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 Ibuprofen PM
Generic name (nonproprietary): diphenhydramine citrate and ibuprofen
Active ingredients: Diphenhydramine citrate — 38 mg/1Ibuprofen — 200 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 079113
Marketing start: Feb 18, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 36800-050_ce7b2954-4165-4ca8-902d-8349eea450beSPL ID ce7b2954-4165-4ca8-902d-8349eea450beSPL set ID 1435e627-144e-4dc8-9ad6-58d91cbd9094RxCUI 895664UNII 4OD433S209, WK2XYI10QM
Pharmacologic class: Histamine-1 Receptor Antagonist; Nonsteroidal Anti-inflammatory Drug

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

N436800005027 followed by a unit qualifier and the quantity

Package 36800-0050-27. 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 Apr 21, 2025.

Indications (excerpt from the label)

Uses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 36800-050

What is NDC 36800-050?: 36800-050 is the product NDC for Topcare Ibuprofen PM, Diphenhydramine citrate 38 mg/1; Ibuprofen 200 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 Ibuprofen PM (Diphenhydramine citrate and ibuprofen).
What is the active ingredient?: Diphenhydramine citrate, Ibuprofen.
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 Ibuprofen PM?: 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 079113

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

FDA NDC Directory listings under ANDA 079113
Product	Strength	Form · route	Labeler	Product NDC
basic care ibuprofen pmdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Amazon.com Services LLC	72288-050
Care One Ibuprofen PMdiphenhydramine citrate and ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	American Sales Company	41520-050
dg health Ibuprofen pmdiphenhydramine citrate and ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Dolgencorp Inc	55910-050
equaline ibuprofen pmdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	United Natural Foods, Inc. dba UNFI	41163-050
equate ibuprofen pmdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Wal-Mart Stores Inc	49035-699
Exchange Select Ibuprofen PMdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Army & Air Force Exchange Service	55301-050
foster and thrive ibuprofen pmdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Strategic Sourcing Services LLC	70677-1131
good neighbor pharmacy ibuprofen pmdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Amerisource Bergen	46122-708
good sense ibuprofen pmdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	L. Perrigo Company	0113-0050
Ibuprofen PMdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Walgreen Company	0363-0050
ibuprofen pmdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Rite Aid Corporation	11822-0050
Ibuprofen PMdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Safeway	21130-623
ibuprofen pmdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Kroger Company	30142-050
ibuprofen pmdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	H E B	37808-703
Ibuprofen PMdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Meijer Distribution Inc	41250-050
ibuprofen pmdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	HyVee Inc	42507-050
ibuprofen pmdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Publix Super Markets Inc	56062-050
ibuprofen pmdiphenhydramine citrate and ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	CVS Pharmacy	59779-050
Leader Ibuprofen PMdiphenhydramine citrate, ibuprofen	Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1	Tablet, Film coatedOral	Cardinal Health 110, LLC. dba Leader	70000-0157
Motrin PMibuprofen and diphenhydramine citrate	Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1	Tablet, CoatedOral	Kenvue Brands LLC	50580-563

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Topcare Ibuprofen PM (Diphenhydramine citrate and ibuprofen) NDC 36800-050