Ibuprofen

Product NDC: 66689-009
11-digit product format: 666890009
Labeler code: 66689
Product ID: 66689-009_3044119c-b14a-4bd9-9f30-c4c7731d1af7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: VistaPharm, Inc.
Application: ANDA074978
Marketing category: ANDA
Marketing start: 2012-08-16
Marketing end: 2019-11-30
Substance: IBUPROFEN
Active strength: 100 mg/5mL
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66689-009		D	Discontinued by firm		2026-08-17
excluded package	package	66689-009	66689-009-50	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66689-009-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66689-009-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66689-009-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66689-009-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66689-009-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66689-009-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66689-009-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66689-009-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66689-009-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66689-009-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66689-009-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66689-009-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074978-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A074978-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074978-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	RS	1998-03-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074978-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074978-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074978-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074978-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074978-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074978-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074978-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074978-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074978-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074978-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074978-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074978-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074978-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074978-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074978-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074978-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074978-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074978-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074978-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074978-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074978-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074978-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074978-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074978-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074978-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074978-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074978-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074978-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074978-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074978-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074978-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074978-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074978-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074978-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074978-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074978-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074978-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074978-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074978-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074978-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66689-009-01	ML - Milliliter	66689-009	0607df43-62ad-450e-a5f3-6e1bae247e3b	1	2013-02-13
66689-009-50	ML - Milliliter	66689-009	75797402-6277-490c-b6e6-fcd37a224737	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN SUSPENSION [VISTAPHARM, INC.]	2
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN SUSPENSION [VISTAPHARM, INC.]	2
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	IBUPROFEN SUSPENSION [VISTAPHARM, INC.]	2
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	IBUPROFEN SUSPENSION [VISTAPHARM, INC.]	2
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	IBUPROFEN SUSPENSION [VISTAPHARM, INC.]	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	IBUPROFEN SUSPENSION [VISTAPHARM, INC.]	2
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN SUSPENSION [VISTAPHARM, INC.]	2
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN SUSPENSION [VISTAPHARM, INC.]	2
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	IBUPROFEN SUSPENSION [VISTAPHARM, INC.]	2
Sucrose	INACTIVE INGREDIENT	C151H8M554	IBUPROFEN SUSPENSION [VISTAPHARM, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN SUSPENSION [VISTAPHARM, INC.]	2
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	IBUPROFEN SUSPENSION [VISTAPHARM, INC.]	2
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN SUSPENSION [CARDINAL HEALTH]	1
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN SUSPENSION [CARDINAL HEALTH]	1
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	IBUPROFEN SUSPENSION [CARDINAL HEALTH]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	IBUPROFEN SUSPENSION [CARDINAL HEALTH]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	IBUPROFEN SUSPENSION [CARDINAL HEALTH]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	IBUPROFEN SUSPENSION [CARDINAL HEALTH]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN SUSPENSION [CARDINAL HEALTH]	1
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN SUSPENSION [CARDINAL HEALTH]	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	IBUPROFEN SUSPENSION [CARDINAL HEALTH]	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	IBUPROFEN SUSPENSION [CARDINAL HEALTH]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN SUSPENSION [CARDINAL HEALTH]	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	IBUPROFEN SUSPENSION [CARDINAL HEALTH]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Actavis Pharma, Inc.	3d156d13-25d8-4cfc-8285-5f7ebf48cf45	2024-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074978 application number: ANDA074978
Ibuprofen	IBUPROFEN	Proficient Rx LP	72b32512-05c7-4113-b0cc-de9c97de2abb	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074978 application number: ANDA074978

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IBUPROFEN ORAL SUSPENSION USP 100 mg/5 mL	VistaPharm, Inc.	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	4
IBUPROFEN ORAL SUSPENSION USP 100 mg/5 mL	Cardinal Health	2018-10-26	HUMAN PRESCRIPTION DRUG LABEL	3