Henry Schein Ibuprofen

Product NDC: 0404-0017
11-digit product format: 004040017
Labeler code: 0404
Product ID: 0404-0017_3e4c41a0-acc2-ca87-e063-6294a90a7540
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Henry Schein Inc.
Application: ANDA075010
Marketing category: ANDA
Marketing start: 2015-12-15
Substance: IBUPROFEN
Active strength: 200 mg/1
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 mg/1

Field, Values table
Field	Values
Unii	WK2XYI10QM
Rxcui	310965

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-0017-13	Henry Schein Ibuprofen	250 in 1 BOX	TABLET, FILM COATED	250		12
0404-0017-99	Henry Schein Ibuprofen	2 in 1 PACKET	TABLET, FILM COATED	2		12

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0404-0017-13	EA - Each	0404-0017	89b78bed-5d87-4447-8b0a-7d16b8539fc8	1	2019-09-05

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-0017	HENRY SCHEIN IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [HENRY SCHEIN INC.]	11	Current NDC, Legacy NDC, 2 package rows	20241109_267c7c8a-2f3f-1f4d-e054-00144ff8d46c.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310965	ibuprofen 200 MG Oral Tablet	PSN	267c7c8a-2f3f-1f4d-e054-00144ff8d46c	12
310965	ibuprofen 200 MG Oral Tablet	SCD	267c7c8a-2f3f-1f4d-e054-00144ff8d46c	12
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	267c7c8a-2f3f-1f4d-e054-00144ff8d46c	12

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-0017-13	00404001713	250 PACKET in 1 BOX (0404-0017-13) / 2 TABLET, FILM COATED in 1 PACKET (0404-0017-99)	250 packet	2015-12-15	0000-00-00	No	No	Current
0404-0017-99	00404001799	2 in 1 PACKET						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Henry Schein Ibuprofen	Henry Schein Inc. \| Unifirst First Aid Corporation	2025-09-08	HUMAN OTC DRUG LABEL	12