IBU

Product NDC: 68071-3053
Requested package NDC: 68071-3053-6
11-digit product format: 680713053
Labeler code: 68071
Product ID: 68071-3053_1d8e3521-5b6d-3418-e063-6294a90a9c41
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA075682
Marketing category: ANDA
Marketing start: 2008-11-20
Substance: IBUPROFEN
Active strength: 800 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

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075682-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14
A075682-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14
A075682-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075682-001	AB
A075682-002	AB
A075682-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075682-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075682-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075682-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075682-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	800 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197807	Internal RxNorm lookup
206917	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
678e2d16-33f3-67a7-e053-2991aa0a1132	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-3053-0	2024-07-18	IBU ™ Tablets
68071-3053-1	2024-07-18	IBU ™ Tablets
68071-3053-2	2024-07-18	IBU ™ Tablets
68071-3053-4	2024-07-18	IBU ™ Tablets
68071-3053-6	2024-07-18	IBU ™ Tablets
68071-3053-0	2023-01-30	IBU ™ Tablets
68071-3053-1	2023-01-30	IBU ™ Tablets
68071-3053-2	2023-01-30	IBU ™ Tablets
68071-3053-4	2023-01-30	IBU ™ Tablets
68071-3053-6	2023-01-30	IBU ™ Tablets
68071-3053-0	2021-02-11	IBU ™ Tablets
68071-3053-1	2021-02-11	IBU ™ Tablets
68071-3053-2	2021-02-11	IBU ™ Tablets
68071-3053-4	2021-02-11	IBU ™ Tablets
68071-3053-6	2021-02-11	IBU ™ Tablets
68071-3053-0	2021-01-29	IBU ™ Tablets
68071-3053-1	2021-01-29	IBU ™ Tablets
68071-3053-2	2021-01-29	IBU ™ Tablets
68071-3053-4	2021-01-29	IBU ™ Tablets
68071-3053-6	2021-01-29	IBU ™ Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-3053-0	IBU	12 in 1 BOTTLE	TABLET	12	4
68071-3053-1	IBU	120 in 1 BOTTLE	TABLET	120	4
68071-3053-2	IBU	20 in 1 BOTTLE	TABLET	20	4
68071-3053-4	IBU	40 in 1 BOTTLE	TABLET	40	4
68071-3053-6	IBU	60 in 1 BOTTLE	TABLET	60	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3053	IBU (IBUPROFEN) TABLET [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 5 package rows	20240720_678e2d16-33f3-67a7-e053-2991aa0a1132.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals, Inc.	72ec2491-924d-460f-9510-62d624d54b59	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Golden State Medical Supply, Inc.	bbf4821d-f9fc-9f6e-e053-2a95a90a5253	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	4522b794-5c93-44cd-e063-6394a90ab39a	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	45223597-0ea8-b275-e063-6394a90a8412	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	4522cb9e-4999-c455-e063-6294a90a294f	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Proficient Rx LP	a7098fa1-b5ae-485e-ada9-64154f81fb6a	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Golden State Medical Supply, Inc.	3ff501eb-5ae3-8824-e063-6394a90ac58e	2025-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	ba86e936-ef72-43e5-aebf-f2c788fe2266	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	8ea0e303-3967-4d71-8255-ac42a841ce28	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Dr. Reddy's Laboratories Limited	24731405-219c-79b4-ecf0-7d5fbfda94ba	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBU	RedPharm Drug, Inc.	4db219dc-ea48-490c-e054-00144ff88e88	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31e6005b-492e-7936-e063-6394a90ad801	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31e6ac7a-fa3e-4dd4-e063-6294a90a29af	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	7650f84b-92f2-4065-8ef2-f5de5bd7002b	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	NuCare Pharmaceuticals,Inc.	593d9870-0213-75e6-e053-2991aa0a0eff	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	NuCare Pharmaceuticals Inc.	575c275c-3e1a-0572-e053-2991aa0adabd	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	NuCare Pharmaceuticals,Inc.	678e2d16-33f3-67a7-e053-2991aa0a1132	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682 ndc (package): 68071-3053-6 ndc (product): 68071-3053 ndc11 (package): 68071305306
IBU	IBUPROFEN	Proficient Rx LP	ea6f626d-cda3-46e2-9ac9-4e72204cb726	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	b0f03994-b744-4d66-95b7-8c86217882bc	2021-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd	2021-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682

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
206917	Ibu 800 MG Oral Tablet	PSN	678e2d16-33f3-67a7-e053-2991aa0a1132	4
197807	ibuprofen 800 MG Oral Tablet	PSN	678e2d16-33f3-67a7-e053-2991aa0a1132	4
206917	ibuprofen 800 MG Oral Tablet [Ibu]	SBD	678e2d16-33f3-67a7-e053-2991aa0a1132	4
197807	ibuprofen 800 MG Oral Tablet	SCD	678e2d16-33f3-67a7-e053-2991aa0a1132	4
206917	Ibu 800 MG Oral Tablet	SY	678e2d16-33f3-67a7-e053-2991aa0a1132	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3053-6	68071305306	60 TABLET in 1 BOTTLE (68071-3053-6)	60 tablet	2018-03-16	0000-00-00	No	No	Current

IBU