Application 075086

Type: ANDA
Sponsor: AKORN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	INJECTABLE;INJECTION	5MG/ML	No	No

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
A075086-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP		1998-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075086-001	AP

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075086-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	1998-04-09	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075086-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075086-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075086-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075086-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075086-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075086-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075086-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075086-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075086-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075086-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075086-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075086-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075086-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075086-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075086-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075086-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075086-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075086-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075086-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075086-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075086-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075086-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075086-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075086-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075086-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075086-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075086-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075086-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075086-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075086-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075086-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075086-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075086-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075086-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075086-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075086-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075086-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075086-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075086-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075086-001	AP	1	`f41ea6bd6efb…`

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 2 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	04a85be5-f746-418e-8e37-292703f16934	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Cardinal Health 107, LLC	bdb9e7cf-bfbb-48b4-a8be-9038820d8279	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	REMEDYREPACK INC.	5e935265-d0fc-4223-835f-72426eeea6c4	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3d594530-885f-45c7-b8a5-fd7e503ff83f	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	bb32d681-9a83-431e-9984-a5cee2c94852	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	839af3af-4040-4cf4-8d4a-881a053514cc	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Macleods Pharmaceuticals Limited	850566b1-0c8e-42bc-85fa-c8ee710f34ba	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	a469b24a-fbec-4a2d-8b4c-b62c2b2c66f6	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	734beeef-3968-4137-af2c-276e8a9317df	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	e99e1446-9c85-478c-9e23-a5f4104bbd22	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	GLENMARK PHARMACEUTICALS INC., USA	fb1606ea-1cff-46fd-b8e5-8135da76436c	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Northwind Health Company, LLC	106b33e3-b199-e555-e063-6294a90a5af5	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Northwind Health Company, LLC	09a5d332-347b-e73d-e063-6294a90a67ed	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Northwind Health Company, LLC	f29febd6-5a27-eb83-e053-2a95a90a5b7d	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	090aa3a9-910e-4f96-b748-783109aa96e6	2025-12-12	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Cardizem CD	DILTIAZEM HYDROCHLORIDE	Bausch Health US LLC	1042fa13-e6af-46b9-8008-6c941f0978b1	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	ec7e93b8-666c-4d2f-8d08-07931e09f748	2025-11-27	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Alembic Pharmaceuticals Limited	74bab197-f719-48c0-ac84-c0cf0087b45a	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ab38794a-914d-4bcd-9c6d-1578aa10041a	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	3a620125-898a-47ba-9000-4295c3a3ad72	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: DILTIAZEM HYDROCHLORIDE generic name: DILTIAZEM HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-817	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Akorn, Inc.	ANDA	Current
17478-837	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Akorn, Inc.	ANDA	Current
17478-837	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Akorn, Inc.	ANDA	Current
17478-837	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Akorn, Inc.	ANDA	Current
17478-837	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Akorn	ANDA	Current
17478-937	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Akorn	ANDA	Current
17478-937	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Akorn, Inc.	ANDA	Current
17478-937	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Akorn, Inc.	ANDA	Current
17478-937	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Akorn	ANDA	Current
17478-937	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Akorn	ANDA	Current
17478-937	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Akorn, Inc.	ANDA	Current
71872-7062	Diltiazem Hydrochloride	Diltiazem Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18386	ORIG	2004-06-02
8516	ORIG	2004-06-02
42931	ORIG	1998-04-09