Application 020027

Type: NDA
Sponsor: BIOVAIL LABS INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDIZEM	DILTIAZEM HYDROCHLORIDE	INJECTABLE;INJECTION	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	CARDIZEM	DILTIAZEM HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020027-001	CARDIZEM	DILTIAZEM HYDROCHLORIDE	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-10-24
N020027-003	CARDIZEM	DILTIAZEM HYDROCHLORIDE	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1995-08-18

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020027-001	CARDIZEM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-10-24	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020027-003	CARDIZEM	25MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1995-08-18	`3a93d1ddd44b…`

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 6 · 108 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Golden State Medical Supply, Inc.	5a0f67ad-17d8-a3f4-e063-6394a90afb32	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Safecor Health LLC	fc02db0f-5311-4b61-896e-bfe340832735	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	HF Acquisition Co. LLC DBA HealthFirst	59464700-f7f1-6ab0-e063-6394a90aa778	2026-08-17	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
TIAZAC EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bausch Health US, LLC	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Sagent Pharmaceuticals	9d51c0f6-26b7-4220-83fb-4e736b289e64	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	NORTHSTAR RX LLC	56616fc9-f3f7-8e0a-22c8-a6af106e6b1d	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	f7137458-0db3-7ecd-e053-6394a90a5f95	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	e66665e8-22eb-f5cd-e053-2a95a90a72e4	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	ec928ee5-0809-4ba5-82ca-ecfed99ebb5a	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Major Pharmaceuticals	e7476adc-a940-4e76-a1dd-c418de493bc0	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	fb6a6199-bb70-476e-a2a2-b7594c9c001a	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	American Health Packaging	11b43a17-8038-462b-8902-259431ad5256	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	465dbab3-f201-4441-8f55-92a843b5134f	2026-06-19	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Golden State Medical Supply, Inc.	c9f17187-e958-106b-e053-2a95a90a54d8	2026-06-16	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	50df9f09-aa2f-495d-a25c-7c5c0fdffcf0	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hospira, Inc.	bba03666-ff4f-4bf6-fa92-78e1ec2d9073	2026-05-24	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	76e04232-b3da-48e8-a944-5f4f97a508df	2026-05-13	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	f276d9fe-a685-4d99-ad82-d4452ef4ba98	2026-05-08	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Zydus Lifesciences Limited	8329d0ac-d68c-48d2-9cbc-e1a1b60192d9	2026-05-01		Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	04a85be5-f746-418e-8e37-292703f16934	2026-04-29	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
1913	SUPPL	2004-12-30