Ibuprofen

Product NDC: 69452-212
11-digit product format: 694520212
Labeler code: 69452
Product ID: 69452-212_0d805053-0600-f7dc-e063-6394a90a8c40
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA078682
Marketing category: ANDA
Marketing start: 2018-11-01
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

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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	69452-212	69452-212-11	D	Discontinued by firm	2026-10-05
excluded package	package	69452-212	69452-212-15	D	Discontinued by firm	2026-10-05
excluded package	package	69452-212	69452-212-20	D	Discontinued by firm	2026-10-05
excluded package	package	69452-212	69452-212-78	D	Discontinued by firm	2026-10-05
excluded package	package	69452-212	69452-212-79	D	Discontinued by firm	2026-10-05
excluded package	package	69452-212	69452-212-83	D	Discontinued by firm	2026-10-05

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 2 · 72 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	69452-212-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	69452-212-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	69452-212-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	69452-212-83	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	69452-212-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	69452-212-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	69452-212-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	69452-212-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	69452-212-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	69452-212-83	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	69452-212-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	69452-212-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	69452-212-79	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	69452-212-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	69452-212-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	69452-212-83	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	69452-212-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	69452-212-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	69452-212-79	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	69452-212-78	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	69452-212-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	69452-212-83	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	69452-212-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	69452-212-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	69452-212-79	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	69452-212-78	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	69452-212-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	69452-212-83	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	69452-212-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	69452-212-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	69452-212-79	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	69452-212-78	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	69452-212-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	69452-212-83	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	69452-212-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	69452-212-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	69452-212-79	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	69452-212-78	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	69452-212-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	69452-212-83	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	69452-212-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	69452-212-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	69452-212-79	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	69452-212-78	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	69452-212-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	69452-212-83	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	69452-212-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	69452-212-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	69452-212-79	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	69452-212-78	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	69452-212-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	69452-212-83	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	69452-212-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	69452-212-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	69452-212-79	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	69452-212-78	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	69452-212-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	69452-212-83	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	69452-212-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	69452-212-15	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078682-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2009-03-24

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 mg/1

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
310964	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
4bc6e8f2-ba95-4352-80ed-b44608fc4936	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69452-212-11	Ibuprofen	20 in 1 BOTTLE	CAPSULE, LIQUID FILLED	20	4
69452-212-15	Ibuprofen	40 in 1 BOTTLE	CAPSULE, LIQUID FILLED	40	4
69452-212-20	Ibuprofen	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100	4
69452-212-78	Ibuprofen	80 in 1 BOTTLE	CAPSULE, LIQUID FILLED	80	4
69452-212-79	Ibuprofen	160 in 1 BOTTLE	CAPSULE, LIQUID FILLED	160	4
69452-212-83	Ibuprofen	300 in 1 BOTTLE	CAPSULE, LIQUID FILLED	300	4
69452-212-90	Ibuprofen	360 in 1 BOTTLE	CAPSULE, LIQUID FILLED	360	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-212	IBUPROFEN CAPSULE, LIQUID FILLED [BIONPHARMA INC.]	4	Current NDC, Legacy NDC, 7 package rows	20231228_4bc6e8f2-ba95-4352-80ed-b44608fc4936.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 3 · 60 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Gobrands, Inc. (Goodnow)	04e1b176-b74a-413e-a8e1-dd3764b9aa8b	2026-09-01	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	Safeway, Inc.	57f06daf-690d-44a7-95a5-468732949750	2026-08-19	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen mini dye free	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC.	552d9018-cc7e-7e1a-e063-6294a90a3322	2026-06-26	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	TOP CARE (Topco Associates LLC)	fb842f4d-1228-9a52-e053-6294a90adb41	2026-06-26	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen Mini Dye Free	IBUPROFEN	CVS Pharmacy	42c7dbec-2e53-70ae-e063-6294a90a16e6	2026-06-25	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	TOP CARE (Topco Associates LLC)	c62cc12f-5a0e-389a-e053-2995a90a208c	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	TOP CARE (Topco Associates LLC)	c6297c23-3b27-c0c6-e053-2995a90a3e76	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	MEIJER DISTRIBUTION INC.	a139e495-3dbf-4998-e053-2a95a90ac136	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
pain relief	IBUPROFEN	Bionpharma Inc.	a14ca126-fada-c903-e053-2995a90ae72d	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	HEB	ca4be24c-5d92-ddc9-e053-2a95a90aa5a7	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	DOLGENCORP INC	03138a6f-653a-f359-e063-6394a90ac5d6	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN CAPSULE	PUBLIX SUPER MARKETS INC	10a6eba7-e400-ce97-e063-6294a90af3bd	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
IBUPROFEN	IBUPROFEN	DISCOUNT DRUG MART, INC.	d07ea9e3-88b0-4aa0-903a-10555dcca37d	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	DISCOUNT DRUG MART, INC.	aae40114-343e-12da-e053-2a95a90a9213	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	BJWC	0ca0b6cf-7d1f-4673-b9b9-48f78d80c00a	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
pain relief	IBUPROFEN	Bionpharma Inc.	2b4ecdd8-627a-445f-8ddc-f2b6c832c1e8	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
dye-free pain relief	IBUPROFEN	Bionpharma Inc.	c46c9c36-8844-7b50-e053-2a95a90aa0e9	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
dye-free pain relief	IBUPROFEN	Bionpharma Inc.	4227d0b7-846a-dcb0-e063-6294a90af7d7	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC.	3c1c1b65-f57f-62b0-e063-6294a90a1021	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682
Ibuprofen	IBUPROFEN	Chain Drug Marketing Association, Inc.	3802982a-2373-9ca3-e063-6394a90a0ab7	2026-06-23	Warnings	Exact identifier application applno (ANDA): 078682 application number: ANDA078682

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
310964	ibuprofen 200 MG Oral Capsule	PSN	4bc6e8f2-ba95-4352-80ed-b44608fc4936	4
310964	ibuprofen 200 MG Oral Capsule	SCD	4bc6e8f2-ba95-4352-80ed-b44608fc4936	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-212-11	69452021211	20 in 1 BOTTLE					Historical
69452-212-15	69452021215	40 in 1 BOTTLE					Historical
69452-212-20	69452021220	100 in 1 BOTTLE					Historical
69452-212-78	69452021278	80 in 1 BOTTLE					Historical
69452-212-79	69452021279	160 in 1 BOTTLE					Historical
69452-212-83	69452021283	300 in 1 BOTTLE					Historical
69452-212-90	69452021290	360 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-212-90)	2021-02-04	0000-00-00	No	No	Current