Over-the-counter drug · ANDA

Leader Ibuprofen PM NDC 70000-0157

diphenhydramine citrate, ibuprofen · Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · Cardinal Health 110, LLC. dba Leader

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0157Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0157Add 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
70000-0157-1700000157011 BOTTLE in 1 CARTON (70000-0157-1) / 40 TABLET, FILM COATED in 1 BOTTLEMarketed from Nov 23, 2016
70000-0157-3700000157031 BOTTLE in 1 CARTON (70000-0157-3) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from Nov 21, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Leader Ibuprofen PM
Generic name (nonproprietary)
diphenhydramine citrate, ibuprofen
Active ingredients
Diphenhydramine citrate — 38 mg/1Ibuprofen — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079113
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 70000-0157_3987ffc4-5b9d-465e-a269-5dadb8ce95b2SPL ID 3987ffc4-5b9d-465e-a269-5dadb8ce95b2SPL set ID b19ad305-4464-4404-a011-584fa0c08521RxCUI 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

N470000015701 followed by a unit qualifier and the quantity

Package 70000-0157-01. 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 • 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)

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
ProductStrengthForm · routeLabelerProduct NDC
Exchange Select Ibuprofen PMdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralArmy & Air Force Exchange Service55301-050
up and up ibuprofen pmdiphenhydramine citrate and ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralTarget Corporation11673-050
Care One Ibuprofen PMdiphenhydramine citrate and ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-050
good neighbor pharmacy ibuprofen pmdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen46122-708
ibuprofen pmdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralRite Aid Corporation11822-0050
Ibuprofen PMdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-050
ibuprofen pmdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralKroger Company30142-050
equaline ibuprofen pmdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-050
Ibuprofen PMdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralSafeway21130-623
basic care ibuprofen pmdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-050
equate ibuprofen pmdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-699
ibuprofen pmdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-050
Topcare Ibuprofen PMdiphenhydramine citrate and ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralTopco Associates LLC36800-050
ibuprofen pmdiphenhydramine citrate and ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralCVS Pharmacy59779-050
good sense ibuprofen pmdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralL. Perrigo Company0113-0050
foster and thrive ibuprofen pmdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1131
Motrin PMibuprofen and diphenhydramine citrateIbuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1Tablet, CoatedOralKenvue Brands LLC50580-563
dg health Ibuprofen pmdiphenhydramine citrate and ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralDolgencorp Inc55910-050
ibuprofen pmdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralH E B37808-703
Ibuprofen PMdiphenhydramine citrate, ibuprofenDiphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1Tablet, Film coatedOralWalgreen Company0363-0050

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