Application 071268

Type: ANDA
Sponsor: CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	600MG	No	No
002	IBUPROFEN	IBUPROFEN	TABLET;ORAL	400MG	No	No
003	IBUPROFEN	IBUPROFEN	TABLET;ORAL	800MG	No	No

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	Approval date
A071268-001	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15
A071268-002	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15
A071268-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071268-001	AB
A071268-002	AB
A071268-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`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	A071268-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071268-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071268-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071268-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071268-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071268-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071268-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071268-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071268-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071268-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071268-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071268-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071268-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071268-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071268-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071268-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071268-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071268-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071268-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071268-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071268-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071268-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071268-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071268-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071268-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071268-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071268-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071268-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071268-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071268-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071268-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071268-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071268-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071268-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071268-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071268-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071268-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071268-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071268-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071268-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	42b6faf5-ef47-6a7a-e063-6394a90ac409	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071268 application number: ANDA071268
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	f4d6372a-d560-0e14-e053-2a95a90a435a	2024-12-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071268 application number: ANDA071268
Ibuprofen	IBUPROFEN	Florida Pharmaceutical Products, LLC	c1733fdb-5eed-2094-e053-2995a90a6c8e	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071268 application number: ANDA071268 ndc (product): 71921-182 ndc (product): 71921-181 ndc (product): 71921-180

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68071-2739	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2756	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2756	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2759	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2789	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2789	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2789	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2789	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2797	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2798	Ibuprofen	Ibuprofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8201	Ibuprofen	Ibuprofen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8244	Ibuprofen	Ibuprofen	Preferred Pharmaceuticals Inc.	ANDA	Current
71921-180	Ibuprofen	Ibuprofen	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-180	Ibuprofen	Ibuprofen	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-181	Ibuprofen	Ibuprofen	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-181	Ibuprofen	Ibuprofen	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-182	Ibuprofen	Ibuprofen	Florida Pharmaceutical Products, LLC	ANDA	Current
71921-182	Ibuprofen	Ibuprofen	Florida Pharmaceutical Products, LLC	ANDA	Current