Application 075853

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/VIAL	No	Yes

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

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
A075853-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION		RS	2002-12-17

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075853-001	DILTIAZEM HYDROCHLORIDE	100MG/VIAL	INJECTABLE / INJECTION	RS	2002-12-17	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hospira, Inc.	bba03666-ff4f-4bf6-fa92-78e1ec2d9073	2026-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075853 application number: ANDA075853 ndc (product): 0409-4350
DILTIAZEM HCI	DILTIAZEM HCI	HF Acquisition Co LLC, DBA HealthFirst	99c5813f-1ffe-0eaa-e053-2a95a90a751b	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075853 application number: ANDA075853 ndc (product): 51662-1457

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-4350	Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4350	Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4350	Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4350	Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4350	Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
51662-1457	DILTIAZEM HCI	DILTIAZEM HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1457	DILTIAZEM HCI	DILTIAZEM HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1457	DILTIAZEM HCI	DILTIAZEM HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current