Ibuprofen, Diphenhydramine HCl NDC 69452-205

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-205Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0205Add 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
69452-205-04	69452020504	1 BLISTER PACK in 1 CARTON (69452-205-04) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Nov 1, 2018
69452-205-11	69452020511	20 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-11)Marketed from Nov 1, 2018
69452-205-15	69452020515	40 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-15)Marketed from Nov 1, 2018
69452-205-20	69452020520	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-20)Marketed from Nov 1, 2018
69452-205-78	69452020578	80 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-78)Marketed from Nov 1, 2018

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): Ibuprofen, Diphenhydramine HCl
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.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090397
Marketing start: Nov 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 69452-205_0f6b5911-edb2-4e3a-b121-45c609b4c60eSPL ID 0f6b5911-edb2-4e3a-b121-45c609b4c60eSPL set ID 59a97c31-db90-48e1-ac1b-0f7026c8ec94RxCUI 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

N469452020504 followed by a unit qualifier and the quantity

Package 69452-0205-04. 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 Nov 9, 2018.

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 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
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen, Diphenhydramine HCl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	TARGET Corporation	11673-225
Ibuprofen PMibuprofen, diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	Wal-Mart Stores, Inc.	49035-670
Ibuprofen PMibuprofen, diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	CVS Pharmacy	69842-870
pain relief pmibuprofen and diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	Bionpharma Inc.	69452-507
Ibuprofen PMibuprofen, diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	HEB	59640-020
Ibuprofen PMibuprofen, diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	MEIJER DISTRIBUTION INC.	41250-285
Ibuprofen PMibuprofen, diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	KROGER COMPANY	30142-232
Ibuprofen PMibuprofen and diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	Whole Foods Market, INC.	42681-0061
Ibuprofen, Diphenhydramine HCl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	Rite Aid Corporation	11822-0789
Ibuprofen PMibuprofen, diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	TOP CARE (Topco Associates LLC)	36800-237
pain relief pmibuprofen, diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	Bionpharma Inc.	69452-264
Ibuprofen and Diphenhydramine HClibuprofen, diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	VALU MERCHANDISERS COMPANY	63941-682
Ibuprofen PMibuprofen, diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	CHAIN DRUG MARKETING ASSOCIATION INC.	63868-829
Ibuprofen PMibuprofen, diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	WALGREEN COMPANY	0363-0207
Ibuprofen PMibuprofen, diphenhydramine hcl	Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	Premier Value Alliance LLC	68016-057