NDC codes

FDA NDC Directory
Product NDC (as listed)69452-264Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69452-0264Add 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
69452-264-226945202642269452026422120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-264-22)Marketed from May 1, 2019

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)
pain relief pm
Generic name (nonproprietary)
ibuprofen, diphenhydramine hcl
Active ingredients
Ibuprofen — 200 mg/1Diphenhydramine hydrochloride — 25 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Bionpharma Inc.NDC labeler code 69452
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090397
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 69452-264_f0471f5f-e8eb-fe08-e053-2995a90a50f6SPL ID f0471f5f-e8eb-fe08-e053-2995a90a50f6SPL set ID 58666a5c-fc92-4c8d-9c04-f0c98dc05c56RxCUI 901814UNII WK2XYI10QM, TC2D6JAD40
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

N469452026422 followed by a unit qualifier and the quantity

Package 69452-0264-22. 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)

About NDC 69452-264

What is NDC 69452-264?
69452-264 is the product NDC for pain relief pm, Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 capsule, liquid filled, listed with the FDA by Bionpharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
pain relief pm (Ibuprofen, Diphenhydramine HCl).
What is the active ingredient?
Ibuprofen, Diphenhydramine hydrochloride.
Who is the labeler?
Bionpharma Inc., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for pain relief pm?
14 other product NDCs are listed under this name. See all pain relief pm 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 pain relief pm NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
pain relief pmibuprofen and diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-50769452-0507-78
Pain Relief PMacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHYVEE INC42507-09542507-0095-0342507-0095-17
Pain Relief PMacetaminophen, diphenhydramineDiphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1TabletOralPioneer Life Sciences, LLC72090-03272090-0032-01
Pain Relief PMacetaminophen, diphenhydramineDiphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1TabletOralNUVICARE LLC84324-00584324-0005-01
Pain Relief PMacetaminophen, diphenhydramineDiphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1TabletOralPioneer Life Sciences, LLC72090-00672090-0006-25
Pain Relief PMacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1TabletOralDOLGENCORP, INC.55910-83455910-0834-0155910-0834-05
Pain Relief PMacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralAMERIFOODS TRADING COMPANY61504-09561504-0095-03
Pain Relief PMacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralTopco Associates, LLC36800-55636800-0556-0936800-0556-10
Pain Relief PMacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralStrategic Sourcing Services LLC70677-008170677-0081-01
Pain Relief PMacetaminophen, aspirin, diphenhydramine citrateAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralCVS Pharmacy59779-89459779-0894-12

All 15 pain relief pm NDCs

Other NDCs under ANDA 090397

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

FDA NDC Directory listings under ANDA 090397
ProductStrengthForm · routeLabelerProduct NDC
Ibuprofen and Diphenhydramine HClibuprofen, diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralVALU MERCHANDISERS COMPANY63941-682
Ibuprofen PMibuprofen, diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralWALGREEN COMPANY0363-0207
Ibuprofen PMibuprofen, diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralKROGER COMPANY30142-232
Ibuprofen PMibuprofen, diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralTOP CARE (Topco Associates LLC)36800-237
Ibuprofen PMibuprofen, diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralMEIJER DISTRIBUTION INC.41250-285
Ibuprofen PMibuprofen and diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralWhole Foods Market, INC.42681-0061
Ibuprofen PMibuprofen, diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralWal-Mart Stores, Inc.49035-670
Ibuprofen PMibuprofen, diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralHEB59640-020
Ibuprofen PMibuprofen, diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralCHAIN DRUG MARKETING ASSOCIATION INC.63868-829
Ibuprofen PMibuprofen, diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralPremier Value Alliance LLC68016-057
Ibuprofen PMibuprofen, diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralCVS Pharmacy69842-870
Ibuprofen, Diphenhydramine HClIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralTARGET Corporation11673-225
Ibuprofen, Diphenhydramine HClIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralRite Aid Corporation11822-0789
Ibuprofen, Diphenhydramine HClIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-205
pain relief pmibuprofen and diphenhydramine hclIbuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-507

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