Ibuprofen

Product NDC: 51672-1409
11-digit product format: 516721409
Labeler code: 51672
Product ID: 51672-1409_1eb7c82f-17d4-482f-81e0-8c63a99531bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA209204
Marketing category: ANDA
Marketing start: 2017-06-23
Marketing end: 0000-00-00
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: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51672-1409		D	Discontinued by firm	2026-10-15
excluded package	package	51672-1409	51672-1409-8	D	Discontinued by firm	2026-10-15
excluded package	package	51672-1409	51672-1409-9	D	Discontinued by firm	2026-10-15

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 · 12 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
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	51672-1409-9	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51672-1409-8	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51672-1409-9	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51672-1409-8	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51672-1409-9	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51672-1409-8	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51672-1409-9	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51672-1409-8	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A209204-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB		2017-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209204-001	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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209204-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2017-06-23	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A209204-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209204-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209204-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209204-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
51672-1409-8	2024-08-21	Ibuprofen Oral Suspension USP, 100 mg/5 mL
51672-1409-9	2024-08-21	Ibuprofen Oral Suspension USP, 100 mg/5 mL
51672-1409-8	2024-01-30	Ibuprofen Oral Suspension USP, 100 mg/5 mL
51672-1409-9	2024-01-30	Ibuprofen Oral Suspension USP, 100 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-1409-8	Ibuprofen	118 mL in 1 BOTTLE	SUSPENSION	118	7
51672-1409-8	Ibuprofen	1 in 1 CARTON	SUSPENSION	1	7
51672-1409-9	Ibuprofen	473 mL in 1 BOTTLE	SUSPENSION	473	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-1409-8	ML - Milliliter	51672-1409	bdd82116-10dd-4cd6-bf89-d72a2fa262d9	1	2023-06-06
51672-1409-9	ML - Milliliter	51672-1409	c7e52d12-ddb7-4336-889b-c29935981feb	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-1409	IBUPROFEN SUSPENSION [-SUN PHARMACEUTICAL INDUSTRIES, INC.]	6	Legacy NDC, 3 package rows	20250406_398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e.zip

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	REMEDYREPACK INC.	dda7645f-1666-4c1f-b974-01add2ea79ac	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209204 application number: ANDA209204
Ibuprofen	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	a8b46ae5-67bc-494d-850e-b4e4ed5a33b3	2025-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209204 application number: ANDA209204

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e	7
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e	7
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e	7
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-1409-8	51672140908	1 BOTTLE in 1 CARTON (51672-1409-8) > 118 mL in 1 BOTTLE	1 bottle	2022-07-06	0000-00-00	No	No	Current
51672-1409-9	51672140909	473 mL in 1 BOTTLE (51672-1409-9)	473 ml	2022-07-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Oral Suspension USP, 100 mg/5 mL	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-07-07	HUMAN PRESCRIPTION DRUG LABEL	7