Ibuprofen

Product NDC: 73614-201
11-digit product format: 736140201
Labeler code: 73614
Product ID: 73614-201_2dcbe4bb-fb23-e827-e063-6394a90acf9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Brisk Pharmaceuticals
Application: ANDA202413
Marketing category: ANDA
Marketing start: 2024-05-23
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

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 4 · 135 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
2026-02-19 14:30 UTC	2026-02	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`d8e5a09893c0…`
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…`

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	A202413-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202413-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-003	AB	1	`d8e5a09893c0…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197807	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
2dcbe4bb-fb24-e827-e063-6394a90acf9f	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
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
dfa3f520-409c-432e-b6d3-9250d468c772	Product name	1	20250401
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d8f81258-db12-0761-46cc-8ff6e62e9302	Product name	4	20240422
b7b2fa42-1c77-d724-81f0-87da60a77e79	Product name	3	20240320
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0	Product name	3	20230425
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3	Product name	9	20220928
b72227d6-0388-43bd-995b-b762d2754cd5	Product name	1	20220706
a92d22e0-3af4-f301-bc88-27ff030b0070	Product name	2	20220316
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
64bb7f1a-2c2e-4741-8301-dbfeda7239f6	Product name	1	20190628
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
5ce6ce33-4f2b-3ce0-757d-e520013280cf	Product name	5	20180719
b92a26f1-6926-4817-be73-e26ab4c2146f	Product name	1	20170602
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303
028d6c95-5012-6976-2075-dee0ae6fefe2	Product name	1	20140508
398aa563-bb78-fe0f-46a8-757c40ef28bf	Product name	1	20140508
468b2c08-8adb-8d0f-8257-c6515a061424	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
8959fb29-d86f-c521-666a-b4cb22233594	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	Strength	SPL version
73614-201-03	ClindaCare	30 in 1 BOTTLE	TABLET, FILM COATED	30	800 mg	1
73614-201-03	Ibuprofen	30 in 1 BOTTLE	TABLET, FILM COATED	30		1
73614-201-03	Orapaz	30 in 1 BOTTLE	TABLET, FILM COATED	30	800 mg	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73614-201	CLINDACARE (CLINDAMYCIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE) KIT [BRISK PHARMACEUTICALS]	1	Current NDC	20250215_2df8a89c-38df-c63b-e063-6394a90aaa36.zip
73614-201	IBUPROFEN TABLET, FILM COATED [BRISK PHARMACEUTICALS]	1	Current NDC, 1 package rows	20250213_2dcbe4bb-fb24-e827-e063-6394a90acf9f.zip
73614-201	ORAPAZ (CEPHALEXIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE) KIT [BRISK PHARMACEUTICALS]	1	Current NDC	20250214_2de0b332-58a3-0bb4-e063-6394a90a1a45.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 · 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

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
309114	cephalexin 500 MG Oral Capsule	PSN	2de0b332-58a3-0bb4-e063-6394a90a1a45	1
834127	chlorhexidine gluconate 0.12 % Oral Rinse	PSN	2df8a89c-38df-c63b-e063-6394a90aaa36	1
834127	chlorhexidine gluconate 0.12 % Oral Rinse	PSN	2de0b332-58a3-0bb4-e063-6394a90a1a45	1
197518	clindamycin HCl 150 MG Oral Capsule	PSN	2df8a89c-38df-c63b-e063-6394a90aaa36	1
197807	ibuprofen 800 MG Oral Tablet	PSN	2dcbe4bb-fb24-e827-e063-6394a90acf9f	1
197807	ibuprofen 800 MG Oral Tablet	PSN	2df8a89c-38df-c63b-e063-6394a90aaa36	1
197807	ibuprofen 800 MG Oral Tablet	PSN	2de0b332-58a3-0bb4-e063-6394a90a1a45	1
309114	cephalexin 500 MG Oral Capsule	SCD	2de0b332-58a3-0bb4-e063-6394a90a1a45	1
834127	chlorhexidine gluconate 1.2 MG/ML Mouthwash	SCD	2de0b332-58a3-0bb4-e063-6394a90a1a45	1
834127	chlorhexidine gluconate 1.2 MG/ML Mouthwash	SCD	2df8a89c-38df-c63b-e063-6394a90aaa36	1
197518	clindamycin 150 MG Oral Capsule	SCD	2df8a89c-38df-c63b-e063-6394a90aaa36	1
197807	ibuprofen 800 MG Oral Tablet	SCD	2de0b332-58a3-0bb4-e063-6394a90a1a45	1
197807	ibuprofen 800 MG Oral Tablet	SCD	2df8a89c-38df-c63b-e063-6394a90aaa36	1
197807	ibuprofen 800 MG Oral Tablet	SCD	2dcbe4bb-fb24-e827-e063-6394a90acf9f	1
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	2de0b332-58a3-0bb4-e063-6394a90a1a45	1
834127	chlorhexidine gluconate 0.12 % Mouthwash	SY	2de0b332-58a3-0bb4-e063-6394a90a1a45	1
834127	chlorhexidine gluconate 0.12 % Mouthwash	SY	2df8a89c-38df-c63b-e063-6394a90aaa36	1
834127	chlorhexidine gluconate 0.12 % Oral Rinse	SY	2df8a89c-38df-c63b-e063-6394a90aaa36	1
834127	chlorhexidine gluconate 0.12 % Oral Rinse	SY	2de0b332-58a3-0bb4-e063-6394a90a1a45	1
197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY	2df8a89c-38df-c63b-e063-6394a90aaa36	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
73614-201-03	73614020103	30 TABLET, FILM COATED in 1 BOTTLE (73614-201-03)	2025-02-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orapaz	Brisk Pharmaceuticals	2025-02-11	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP 800 mg	Brisk Pharmaceuticals	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL	1
ClindaCare	Brisk Pharmaceuticals	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL	1