Ibuprofen Oral

Product NDC: 72162-1909
11-digit product format: 721621909
Labeler code: 72162
Product ID: 72162-1909_34f87cb5-33ec-b8ce-e063-6394a90a515b
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen Oral
Dosage form: SUSPENSION
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA210602
Marketing category: ANDA
Marketing start: 2025-05-12
Substance: IBUPROFEN
Active strength: 100 mg/5mL
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 72162-1909_34f87cb5-33ec-b8ce-e063-6394a90a515b
SPL ID: 34f87cb5-33ec-b8ce-e063-6394a90a515b
Product type: HUMAN OTC DRUG
Finished product: Yes
Brand name base: Ibuprofen Oral
Generic name: Ibuprofen Oral
Dosage form: SUSPENSION
Route: ORAL
Marketing start: 2025-05-12
Marketing category: ANDA
Application number: ANDA210602
Pharmacologic classes: Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
IBUPROFEN	100 mg/5mL

Package NDC	Description	Marketing start	Sample
72162-1909-2	1 BOTTLE in 1 CARTON (72162-1909-2) / 118 mL in 1 BOTTLE	2025-05-12	No

UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1909-2	72162190902	1 BOTTLE in 1 CARTON (72162-1909-2) / 118 mL in 1 BOTTLE	1 bottle	2025-05-12	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Ibuprofen Oral Suspension USP, 100 mg/5 mL (OTC)	Bryant Ranch Prepack	2025-05-12	HUMAN OTC DRUG LABEL	100