Application 074505

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	12.5MG	No	No
002	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	25MG	No	No
003	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	50MG	No	No
004	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
A074505-001	CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13
A074505-002	CAPTOPRIL	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13
A074505-003	CAPTOPRIL	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13
A074505-004	CAPTOPRIL	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A074505-001	AB
A074505-002	AB
A074505-003	AB
A074505-004	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 5 · 168 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
2026-08-18 06:07:40	2026-07	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074505-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074505-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074505-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074505-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074505-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074505-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-004	AB	1	`d8e5a09893c0…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Captopril	CAPTOPRIL	Golden State Medical Supply, Inc.	d117c8bd-50a8-7355-e053-2a95a90ac70f	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074505 application number: ANDA074505 ndc (product): 51407-603 ndc (product): 51407-601 ndc (product): 51407-602 ndc (product): 51407-600
Captopril	CAPTOPRIL	PD-Rx Pharmaceuticals, Inc.	65ed6e70-f1ee-437e-965c-d1b1fdadd832	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074505 application number: ANDA074505 ndc (product): 55289-344
Captopril	CAPTOPRIL	Hikma Pharmaceuticals USA Inc.	607687f4-63cf-411c-a20b-21d238a6b7a7	2024-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074505 application number: ANDA074505 ndc (product): 0143-1173 ndc (product): 0143-1171 ndc (product): 0143-1174 ndc (product): 0143-1172
Captopril	CAPTOPRIL	American Health Packaging	9b54feb0-13cd-46a8-9924-f12880381196	2024-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074505 application number: ANDA074505 ndc (product): 60687-315 ndc (product): 60687-304

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 64 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1171	Captopril	Captopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1171	Captopril	Captopril	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1171	Captopril	Captopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1171	Captopril	Captopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1172	Captopril	Captopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1172	Captopril	Captopril	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1172	Captopril	Captopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1172	Captopril	Captopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1173	Captopril	Captopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1173	Captopril	Captopril	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1173	Captopril	Captopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1173	Captopril	Captopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1174	Captopril	Captopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1174	Captopril	Captopril	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1174	Captopril	Captopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1174	Captopril	Captopril	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0904-5045	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
0904-5045	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
0904-5045	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
0904-5045	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
0904-5046	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
0904-5046	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
0904-5046	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
0904-5046	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
0904-5047	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
0904-5047	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
0904-5047	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
0904-5047	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
21695-477	Captopril	Captopril	Rebel Distributors Corp	ANDA	Current
21695-478	Captopril	Captopril	Rebel Distributors Corp	ANDA	Current
50090-1840	Captopril	Captopril	A-S Medication Solutions	ANDA	Current
51407-600	Captopril	Captopril	Golden State Medical Supply, Inc.	ANDA	Current
51407-601	Captopril	Captopril	Golden State Medical Supply, Inc.	ANDA	Current
51407-602	Captopril	Captopril	Golden State Medical Supply, Inc.	ANDA	Current
51407-603	Captopril	Captopril	Golden State Medical Supply, Inc.	ANDA	Current
53808-0217	Captopril	Captopril	DOH CENTRAL PHARMACY	ANDA	Current
53808-0348	Captopril	Captopril	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0359	Captopril	Captopril	DOH CENTRAL PHARMACY	ANDA	Current
53808-0911	Captopril	Captopril	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0912	Captopril	Captopril	State of Florida DOH Central Pharmacy	ANDA	Current
55289-344	Captopril	Captopril	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-344	Captopril	Captopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-344	Captopril	Captopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-344	Captopril	Captopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-344	Captopril	Captopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-344	Captopril	Captopril	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60687-304	Captopril	Captopril	American Health Packaging	ANDA	Current
60687-304	Captopril	Captopril	American Health Packaging	ANDA	Current
60687-304	Captopril	Captopril	American Health Packaging	ANDA	Current
60687-304	Captopril	Captopril	American Health Packaging	ANDA	Current
60687-315	Captopril	Captopril	American Health Packaging	ANDA	Current
60687-315	Captopril	Captopril	American Health Packaging	ANDA	Current
60687-315	Captopril	Captopril	American Health Packaging	ANDA	Current
60687-315	Captopril	Captopril	American Health Packaging	ANDA	Current
63629-1338	Captopril	Captopril	Bryant Ranch Prepack	ANDA	Current
63629-1338	Captopril	Captopril	Bryant Ranch Prepack	ANDA	Current
63629-1338	Captopril	Captopril	Bryant Ranch Prepack	ANDA	Current
66267-040	Captopril	Captopril	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-040	Captopril	Captopril	NuCare Pharmaceuticals, Inc.	ANDA	Current
67296-0677	Captopril	Captopril	RedPharm Drug Inc.	ANDA	Current
67296-0678	Captopril	Captopril	RedPharm Drug Inc.	ANDA	Current
68151-0050	Captopril	Captopril	Carilion Materials Management	ANDA	Current
68788-9842	Captopril	Captopril	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9843	Captopril	Captopril	Preferred Pharmaceuticals, Inc.	ANDA	Current