Diltiazem Hydrochloride

Product NDC: 33261-829
11-digit product format: 332610829
Labeler code: 33261
Product ID: 33261-829_4da3b18f-eb1c-49ac-8387-07e16931208d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA075116
Marketing category: ANDA
Marketing start: 1999-12-28
Marketing end: 0000-00-00
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 240 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	33261-829		I	Inactivated by FDA		2026-09-14
excluded package	package	33261-829	33261-829-30	I	Inactivated by FDA		2026-09-14

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 · 42 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	33261-829-30	`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	33261-829-30	`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	33261-829-30	`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	33261-829-30	`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	33261-829-30	`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	33261-829-30	`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	33261-829-30	`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	33261-829-30	`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	33261-829-30	`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	33261-829-30	`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	33261-829-30	`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	33261-829-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-829-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-829-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-829-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	33261-829-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	33261-829-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	33261-829-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	33261-829-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	33261-829-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	33261-829-30	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075116-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23
A075116-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23
A075116-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23
A075116-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075116-001	AB3
A075116-002	AB3
A075116-003	AB3
A075116-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A075116-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075116-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075116-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075116-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075116-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075116-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075116-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075116-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075116-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075116-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075116-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075116-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075116-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075116-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075116-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075116-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075116-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075116-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075116-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075116-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075116-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075116-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075116-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075116-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075116-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075116-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075116-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075116-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075116-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075116-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075116-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075116-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075116-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075116-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075116-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075116-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075116-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075116-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075116-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075116-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1999-12-23	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075116-001	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075116-002	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075116-003	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075116-004	AB3	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075116-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075116-002	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075116-003	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075116-004	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075116-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075116-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075116-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075116-004	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075116-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075116-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075116-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075116-004	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075116-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075116-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075116-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075116-004	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075116-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075116-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075116-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075116-004	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075116-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075116-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075116-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075116-004	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075116-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075116-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075116-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075116-004	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075116-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075116-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075116-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075116-004	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075116-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075116-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075116-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075116-004	AB3	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33261-829-30	2020-01-31	C162847	48780-1	9d75b9d0-7624-f424-e053-dadaa90a57ce	DILTIAZEM HYDROCHLORIDE Extended-release Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33261-829-30	Diltiazem Hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-829-30	EA - Each	33261-829	82604d0a-3be4-4711-8916-72eb26350dbe	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DILTIAZEM HYDROCHLORIDE	ACTIVE INGREDIENT	OLH94387TE	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
DILTIAZEM	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-829	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20140107_bad984eb-797e-42b4-8547-a8b46fc2fe9e.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	090aa3a9-910e-4f96-b748-783109aa96e6	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075116 application number: ANDA075116
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	c1ef9e90-6ff0-4ee5-86a3-1efee9c36789	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075116 application number: ANDA075116
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	OCEANSIDE PHARMACEUTICALS	43892b97-449d-45bc-bb09-29d47c655d65	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075116 application number: ANDA075116
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	54b0b11d-adc0-4afb-e054-00144ff88e88	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075116 application number: ANDA075116
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7cdb473a-e6d5-48e8-e053-2a91aa0aaeb7	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075116 application number: ANDA075116
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	609e97e5-ebc7-4268-84ea-f279284c89e2	2020-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075116 application number: ANDA075116

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	bad984eb-797e-42b4-8547-a8b46fc2fe9e	1
830837	24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule	SCD	bad984eb-797e-42b4-8547-a8b46fc2fe9e	1
830837	diltiazem HCl 240 MG 24 HR Extended Release Oral Capsule	SY	bad984eb-797e-42b4-8547-a8b46fc2fe9e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-829-30	33261082930	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DILTIAZEM HYDROCHLORIDE Extended-release Capsules, USP	Aidarex Pharmaceuticals LLC	2013-12-28	HUMAN PRESCRIPTION DRUG LABEL	1