Ibuprofen

Product NDC: 59651-032
11-digit product format: 596510032
Labeler code: 59651
Product ID: 59651-032_ab75fb4b-5a86-477e-846f-dbea85abcfc6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen Oral
Dosage form: SUSPENSION
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA209178
Marketing category: ANDA
Marketing start: 2018-02-16
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: 2027-12-31
Current FDA listing: Yes

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
A209178-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB		2018-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209178-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		2018-02-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209178-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	AB	2018-02-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209178-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209178-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209178-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209178-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209178-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209178-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209178-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209178-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209178-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209178-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209178-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209178-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209178-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209178-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209178-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209178-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209178-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209178-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209178-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209178-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209178-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209178-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209178-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209178-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209178-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209178-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209178-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209178-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209178-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209178-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197803	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
758eeb45-e599-4c1a-969d-8fa33f27bf14	Available on FDA.report

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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
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
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59651-032-12	Ibuprofen	1 in 1 CARTON	SUSPENSION	1	15
59651-032-12	Ibuprofen	120 mL in 1 BOTTLE	SUSPENSION	120	15
59651-032-47	Ibuprofen	1 in 1 CARTON	SUSPENSION	1	15
59651-032-47	Ibuprofen	473 mL in 1 BOTTLE	SUSPENSION	473	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-032-12	ML - Milliliter	59651-032	e48d888b-4121-43c6-834e-2cb34be943fc	1	2018-04-19
59651-032-47	ML - Milliliter	59651-032	acd22063-5792-41eb-b0ac-41db10ee35d4	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-032	IBUPROFEN (IBUPROFEN ORAL) SUSPENSION [AUROBINDO PHARMA LIMITED]	14	Current NDC, Legacy NDC, 4 package rows	20240808_758eeb45-e599-4c1a-969d-8fa33f27bf14.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 ORAL	Aurobindo Pharma Limited	758eeb45-e599-4c1a-969d-8fa33f27bf14	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209178 application number: ANDA209178 ndc (product): 59651-032
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	141b7964-cce6-74e4-e063-6294a90af746	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209178 application number: ANDA209178

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	758eeb45-e599-4c1a-969d-8fa33f27bf14	15
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	758eeb45-e599-4c1a-969d-8fa33f27bf14	15
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	758eeb45-e599-4c1a-969d-8fa33f27bf14	15
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	758eeb45-e599-4c1a-969d-8fa33f27bf14	15
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	141b7964-cce6-74e4-e063-6294a90af746	1
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	141b7964-cce6-74e4-e063-6294a90af746	1
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	141b7964-cce6-74e4-e063-6294a90af746	1
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	141b7964-cce6-74e4-e063-6294a90af746	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59651-032-12	59651003212	1 BOTTLE in 1 CARTON (59651-032-12) / 120 mL in 1 BOTTLE	1 bottle	2018-02-16	0000-00-00	No	No	Current
59651-032-47	59651003247	1 BOTTLE in 1 CARTON (59651-032-47) / 473 mL in 1 BOTTLE	1 bottle	2018-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Oral Suspension USP Rx Only	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2026-03-30	Human Prescription Drug Label	15
Ibuprofen Oral Suspension USP Rx Only	NuCare Pharmaceuticals,Inc.	2024-03-20	HUMAN PRESCRIPTION DRUG LABEL	1