Ibuprofen

Product NDC: 67296-1633
11-digit product format: 672961633
Labeler code: 67296
Product ID: 67296-1633_b8d0796c-80c7-1386-e053-2a95a90a676f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA202413
Marketing category: ANDA
Marketing start: 2017-04-15
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 600 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	67296-1633		I	Inactivated by FDA		2026-08-03
excluded package	package	67296-1633	67296-1633-3	I	Inactivated by FDA		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202413-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23
A202413-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23
A202413-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23
A202413-004	IBUPROFEN	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202413-001	AB
A202413-002	AB
A202413-003	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 3 · 99 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
2024-10-29 15:01 UTC	2024-10	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-10-29 15:01 UTC	2024-10	A202413-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202413-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202413-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202413-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202413-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202413-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202413-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202413-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202413-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202413-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202413-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202413-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202413-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202413-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202413-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202413-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202413-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202413-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202413-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202413-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202413-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202413-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202413-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202413-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202413-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202413-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202413-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202413-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202413-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202413-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202413-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202413-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202413-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202413-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202413-001	AB	1	`8869cabd3fbd…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	2572ed69-d5a7-4513-a202-aca3230e7ec5	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	656658cc-8cf0-42b6-af4f-4e3ab7648625	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	c0156053-add5-4bd5-b89f-f90df2e73be4	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	3a38add6-a114-4e18-836c-3bfc727db231	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Redpharm Drug	5302291e-4816-8495-e063-6394a90a9cc0	2026-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	404df13d-4ada-4324-9eed-e21f5d5043a4	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	ST. MARY'S MEDICAL PARK PHARMACY	4e67aef4-c3ac-232a-e063-6394a90a3a85	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	886c974c-0d32-4a1b-8f54-40c2c12efa45	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	2e0f74a5-b8f3-fc81-e063-6394a90a647a	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Proficient Rx LP	ab2f1a30-611b-41b6-9baf-6a82305da845	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	4b34b58b-2cf7-9aa8-e063-6294a90a0658	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	A-S Medication Solutions	0170876a-d8cd-4a2d-8397-db2acdf72ffb	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	70e191ef-8fad-49eb-9850-fceea119e92f	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	b84ea215-e61d-4c00-8a34-d47c4080779b	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Coupler LLC	4831785a-cde2-79a2-e063-6294a90a9a40	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	AiPing Pharmaceutical, Inc.	3e131710-2579-446e-8076-f602ecea813f	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Chartwell RX, LLC	39f2664f-6c0a-4726-85d7-4227530d4a49	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Redpharm Drug	44f278ac-6bf9-6aef-e063-6394a90a0bb6	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Redpharm Drug	44f5743f-8c98-dc4d-e063-6294a90a6dfa	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Redpharm Drug	44f609dd-c868-493f-e063-6294a90a7138	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1633-3	2023-01-30	C162847	48780-1	f386c649-9fc4-0266-e053-dadaa90a7c1a	Ibuprofen 600mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1633-3	Ibuprofen	30 in 1 BOTTLE	TABLET	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1633	IBUPROFEN TABLET [REDPHARM DRUG, INC.]	3	Legacy NDC, 1 package rows	20210114_888ea2f1-4f64-7d10-e053-2a95a90ad8cb.zip

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
197806	ibuprofen 600 MG Oral Tablet	PSN	888ea2f1-4f64-7d10-e053-2a95a90ad8cb	3
197806	ibuprofen 600 MG Oral Tablet	SCD	888ea2f1-4f64-7d10-e053-2a95a90ad8cb	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1633-3	67296163303	30 TABLET in 1 BOTTLE (67296-1633-3)	30 tablet	2017-04-15	0000-00-00	No	No	Current