Application 020062

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	Yes	No
002	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	180MG	Yes	No
003	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	240MG	Yes	No
004	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	300MG	Yes	No
005	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	360MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020062-001	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10
N020062-002	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27
N020062-003	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27
N020062-004	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27
N020062-005	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N020062-001	AB3
N020062-002	AB3
N020062-003	AB3
N020062-004	AB3
N020062-005	AB3

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 6 · 205 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
2026-02-19 14:30 UTC	2026-02	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	N020062-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-004	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-005	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-004	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-005	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020062-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-004	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-005	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-004	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-005	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-004	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-005	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-004	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-005	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-004	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-005	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-004	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-005	AB3	1	`5bbf6a4d5a75…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cardizem CD	DILTIAZEM HYDROCHLORIDE	Bausch Health US LLC	1042fa13-e6af-46b9-8008-6c941f0978b1	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020062 application number: NDA020062 ndc (product): 0187-0797 ndc (product): 0187-0799 ndc (product): 0187-0798 ndc (product): 0187-0795 ndc (product): 0187-0796

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-0795	Cardizem CD	diltiazem hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0795	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0795	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0795	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0795	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0795	Cardizem CD	diltiazem hydrochloride	Bausch Health Americas Inc.	NDA	Current
0187-0795	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Bausch Health Americas Inc.	NDA	Current
0187-0796	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Bausch Health Americas Inc.	NDA	Current
0187-0797	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Bausch Health Americas Inc.	NDA	Current
0187-0798	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Bausch Health Americas Inc.	NDA	Current
0187-0799	Cardizem CD	diltiazem hydrochloride	Bausch Health US LLC	NDA	Current
68682-521	Diltiazem HCl CD	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-521	Diltiazem HCl CD	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-521	Diltiazem HCl CD	Diltiazem Hydrochloride	Oceanside Pharmaceuticals	NDA	Current
71335-2029	Diltiazem HCl CD	Diltiazem Hydrochloride	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82019	SUPPL	2025-04-28
81953	SUPPL	2025-04-24
62851	SUPPL	2020-05-08
62350	SUPPL	2020-03-27
48412	SUPPL	2017-05-17
45914	SUPPL	2016-11-22
45940	SUPPL	2016-11-21
45087	SUPPL	2016-06-22
1958	SUPPL	2010-11-30
12165	SUPPL	2010-11-22
41138	SUPPL	2001-07-13