diltiazem hydrochloride

Product NDC: 63629-4335
11-digit product format: 636294335
Labeler code: 63629
Product ID: 63629-4335_7c1e835e-80a6-4743-afd5-3dddc0679133
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diltiazem hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA020401
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-09-25
Marketing end: 0000-00-00
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 180 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-4335		D	Discontinued by firm	2026-08-11
excluded package	package	63629-4335	63629-4335-1	D	Discontinued by firm	2026-08-11
excluded package	package	63629-4335	63629-4335-2	D	Discontinued by firm	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4335-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4335-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4335-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4335-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4335-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4335-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4335-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4335-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4335-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4335-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4335-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4335-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4335-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4335-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4335-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4335-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4335-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4335-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4335-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4335-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4335-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4335-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4335-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4335-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4335-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4335-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4335-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4335-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-4335-2	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-4335-1	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020401-001	TIAZAC	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-002	TIAZAC	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-003	TIAZAC	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-004	TIAZAC	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-005	TIAZAC	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-006	TIAZAC	DILTIAZEM HYDROCHLORIDE	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N020401-001	AB4
N020401-002	AB4
N020401-003	AB4
N020401-004	AB4
N020401-005	AB4
N020401-006	AB4

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 7 · 246 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	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	N020401-001	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-002	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-003	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-004	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-005	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-006	AB4	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-001	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-002	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-003	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-004	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-005	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-006	AB4	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020401-001	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-002	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-003	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-004	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-005	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-006	AB4	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-001	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-002	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-003	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-004	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-005	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-006	AB4	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-001	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-002	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-003	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-004	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-005	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-006	AB4	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-001	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-002	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-003	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-004	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-005	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-006	AB4	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-001	AB4	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-002	AB4	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-003	AB4	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-004	AB4	1	`2680178bc6a6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4335-1	2021-07-01	Diltiazem hydrochloride
63629-4335-2	2021-07-01	Diltiazem hydrochloride
63629-4335-1	2019-11-27	Diltiazem hydrochloride
63629-4335-2	2019-11-27	Diltiazem hydrochloride

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DILTIAZEM HYDROCHLORIDE	ACTIVE INGREDIENT	OLH94387TE	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
DILTIAZEM	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TIAZAC EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bausch Health US, LLC	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	58eeb8bc-91d0-4cf8-a0d7-be3548d92196	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Oceanside Pharmaceuticals	862d65cb-a732-4786-b569-bad2eaafddfd	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	c7c6a74e-5f73-4265-a0e0-8fd2cd26909e	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401
DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE	direct rx	c7cf9276-4b4c-10b2-e053-2995a90a3738	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OLH94387TE	DILTIAZEM HYDROCHLORIDE	33286-22-5	DILTIAZEM HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem hydrochloride	Bryant Ranch Prepack \| Biovail Corporation	2009-09-25	HUMAN PRESCRIPTION DRUG LABEL	2