Diltiazem Hydrochloride Extended Release

Product NDC: 0615-7750
11-digit product format: 006157750
Labeler code: 0615
Product ID: 0615-7750_fc028060-53ef-4b79-8767-8a446e53a066
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem Hydrochloride
Dosage form: CAPSULE, COATED, EXTENDED RELEASE
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA074984
Marketing category: ANDA
Marketing start: 1999-12-20
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	0615-7750		D	Discontinued by firm	2026-08-03
excluded package	package	0615-7750	0615-7750-31	D	Discontinued by firm	2026-08-03
excluded package	package	0615-7750	0615-7750-39	D	Discontinued by firm	2026-08-03

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	0615-7750-39	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-7750-31	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	0615-7750-39	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-7750-31	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	0615-7750-39	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-7750-31	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	0615-7750-39	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-7750-31	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	0615-7750-39	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-7750-31	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	0615-7750-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-7750-31	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	0615-7750-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-7750-31	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	0615-7750-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-7750-31	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	0615-7750-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-7750-31	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	0615-7750-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-7750-31	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	0615-7750-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-7750-31	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	0615-7750-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-7750-31	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	0615-7750-39	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-7750-31	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	0615-7750-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-7750-31	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7750-39	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7750-31	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074984-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20
A074984-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20
A074984-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20
A074984-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A074984-001	AB3
A074984-002	AB3
A074984-003	AB3
A074984-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074984-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074984-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074984-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074984-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074984-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074984-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074984-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074984-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074984-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074984-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074984-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074984-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074984-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074984-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074984-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074984-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074984-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074984-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074984-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074984-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074984-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074984-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074984-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074984-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074984-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074984-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074984-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074984-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074984-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074984-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074984-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074984-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074984-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074984-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074984-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074984-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074984-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074984-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074984-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074984-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A074984-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074984-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074984-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074984-004	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074984-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074984-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074984-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074984-004	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074984-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074984-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074984-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074984-004	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074984-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074984-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074984-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074984-004	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074984-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074984-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074984-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074984-004	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074984-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074984-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074984-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074984-004	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074984-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074984-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074984-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074984-004	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074984-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074984-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074984-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074984-004	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074984-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074984-002	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074984-003	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074984-004	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074984-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074984-002	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074984-003	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074984-004	AB3	1	`d06236e962d9…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0615-7750-31	2021-04-19	DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP (Once-a-Day Dosage) Rx Only
0615-7750-39	2021-04-19	DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP (Once-a-Day Dosage) Rx Only
0615-7750-31	2020-01-31	DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP (Once-a-Day Dosage) Rx Only
0615-7750-39	2020-01-31	DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP (Once-a-Day Dosage) Rx Only

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DILTIAZEM HYDROCHLORIDE	ACTIVE INGREDIENT	OLH94387TE	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
DILTIAZEM	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
1-PROPOXY-2-PROPANOL	INACTIVE INGREDIENT	152BY1743W	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
AMMONIO METHACRYLATE COPOLYMER TYPE A	INACTIVE INGREDIENT	8GQS4E66YY	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
AMMONIO METHACRYLATE COPOLYMER TYPE B	INACTIVE INGREDIENT	161H3B14U2	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
IRON SUCROSE	INACTIVE INGREDIENT	FZ7NYF5N8L	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	fb6a6199-bb70-476e-a2a2-b7594c9c001a	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074984 application number: ANDA074984
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	American Health Packaging	11b43a17-8038-462b-8902-259431ad5256	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074984 application number: ANDA074984
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	fe7ca564-16b8-4c54-aa09-3e2ed0c2596a	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074984 application number: ANDA074984
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	de2a0c48-7fc4-4760-b465-a79299876e6e	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074984 application number: ANDA074984
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	74232d69-1a8c-449d-8e8e-85488e6cc8f8	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074984 application number: ANDA074984
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	0e9b4421-bc43-4a77-b49b-e3f53d1e0f01	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074984 application number: ANDA074984
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	a6cc3b99-2c0f-4d8a-8393-ec042ed7c892	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074984 application number: ANDA074984
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a6	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074984 application number: ANDA074984
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	762c3007-b22f-4d35-87b4-191fec8b3a9a	2023-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074984 application number: ANDA074984
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	eed8cfeb-6ec7-4914-b8e0-a5c3d623c9a4	2023-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074984 application number: ANDA074984

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 EXTENDED-RELEASE CAPSULES, USP (Once-a-Day Dosage) Rx Only	NCS HealthCare of KY, Inc dba Vangard Labs	2013-01-17	HUMAN PRESCRIPTION DRUG LABEL	4