Diltiazem Hydrochloride

Product NDC: 71335-1585
11-digit product format: 713351585
Labeler code: 71335
Product ID: 71335-1585_9308bc71-ce3f-429f-9926-d140481ad8ab
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: 2014-08-20
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 240 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-1585		D	Discontinued by firm	2026-08-11
excluded package	package	71335-1585	71335-1585-1	D	Discontinued by firm	2026-08-11
excluded package	package	71335-1585	71335-1585-2	D	Discontinued by firm	2026-08-11
excluded package	package	71335-1585	71335-1585-3	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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1585-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1585-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1585-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1585-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1585-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1585-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1585-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1585-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1585-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1585-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1585-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1585-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1585-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1585-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1585-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1585-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1585-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1585-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1585-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1585-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1585-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-1585-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-1585-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-1585-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-1585-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-1585-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-1585-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-1585-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-1585-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-1585-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-1585-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-1585-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-1585-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-1585-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-1585-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-1585-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diltiazem Hydrochloride
Brand name suffix: EXTENDED RELEASE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DILTIAZEM HYDROCHLORIDE	240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
OLH94387TE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
830837	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c7c6a74e-5f73-4265-a0e0-8fd2cd26909e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
61ebbccf-eedf-453b-940e-dba67b7a5fef	Product name	4	20260107
a8d6eaa3-afcc-47e5-be12-0c9251fc8740	Product name	1	20251124
f6700316-a6ba-5e59-3413-8ede05ae58b9	Product name	7	20250625
8615f7a1-1e8f-8281-8601-d7a637926d1f	Product name	4	20250522
3a9daa2f-bcd1-13de-a1b4-6172caa7f308	Product name	2	20240419
f7129636-cba8-86c2-8bfb-9e2e2a9c7628	Product name	2	20240314
378290be-e30f-0e68-1201-165e93c337e8	Product name	3	20231212
c733b56e-b0b5-4495-9857-0256a8242279	Product name	1	20220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81	Product name	2	20171003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1585-1	Diltiazem HydrochlorideEXTENDED RELEASE	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	103
71335-1585-2	Diltiazem HydrochlorideEXTENDED RELEASE	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	103
71335-1585-3	Diltiazem HydrochlorideEXTENDED RELEASE	18 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	18	103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1585-1	EA - Each	71335-1585	87815833-5063-4731-8436-48778a46333e	1	2025-09-12
71335-1585-2	EA - Each	71335-1585	4eeed151-3b72-4f5e-b1cf-cdc7ff4b05b8	1	2025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1585	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 3 package rows	20250123_c7c6a74e-5f73-4265-a0e0-8fd2cd26909e.zip

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 ndc (product): 71335-1585
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
830837	dilTIAZem HCl 240 MG 24HR Extended Release Oral Capsule	PSN	c7c6a74e-5f73-4265-a0e0-8fd2cd26909e	103
830837	24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule	SCD	c7c6a74e-5f73-4265-a0e0-8fd2cd26909e	103
830837	diltiazem HCl 240 MG 24 HR Extended Release Oral Capsule	SY	c7c6a74e-5f73-4265-a0e0-8fd2cd26909e	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1585-1	71335158501	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1585-1)	2022-02-11	0000-00-00	No	No	Current
71335-1585-2	71335158502	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1585-2)	2022-02-11	0000-00-00	No	No	Current
71335-1585-3	71335158503	18 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1585-3)	2022-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only	Bryant Ranch Prepack	2025-01-21	HUMAN PRESCRIPTION DRUG LABEL	103