Diltiazem Hydrochloride

Product NDC: 21695-404
11-digit product format: 216950404
Labeler code: 21695
Product ID: 21695-404_a5391476-8480-401d-8bb5-0726d8195770
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Rebel Distributors Corp
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-404		I	Inactivated by FDA		2026-08-03
excluded package	package	21695-404	21695-404-30	I	Inactivated by FDA		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 · 44 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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`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	21695-404-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-404-30	`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…`

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
21695-404-30	2019-09-24	C162847	48780-1	934fe258-4ba8-48b1-e053-8cdaa90a720a	DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-404-30	Diltiazem Hydrochloride	30 in 1 BOTTLE	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
21695-404-30	EA - Each	21695-404	5b0a9bf7-fd9e-4048-a4d8-583475153d35	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diltiazem Hydrochloride	ACTIVE INGREDIENT	OLH94387TE	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
Diltiazem	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
AMMONIO METHACRYLATE COPOLYMER TYPE A	INACTIVE INGREDIENT	8GQS4E66YY	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
AMMONIO METHACRYLATE COPOLYMER TYPE B	INACTIVE INGREDIENT	161H3B14U2	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-404	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110103_a5391476-8480-401d-8bb5-0726d8195770.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
830861	dilTIAZem HCl 120 MG 24HR Extended Release Oral Capsule	PSN	a5391476-8480-401d-8bb5-0726d8195770	1
830845	dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule	PSN	a5391476-8480-401d-8bb5-0726d8195770	1
830837	dilTIAZem HCl 240 MG 24HR Extended Release Oral Capsule	PSN	a5391476-8480-401d-8bb5-0726d8195770	1
830861	24 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	a5391476-8480-401d-8bb5-0726d8195770	1
830845	24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule	SCD	a5391476-8480-401d-8bb5-0726d8195770	1
830837	24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule	SCD	a5391476-8480-401d-8bb5-0726d8195770	1
830861	diltiazem HCl 120 MG 24 HR Extended Release Oral Capsule	SY	a5391476-8480-401d-8bb5-0726d8195770	1
830845	diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule	SY	a5391476-8480-401d-8bb5-0726d8195770	1
830837	diltiazem HCl 240 MG 24 HR Extended Release Oral Capsule	SY	a5391476-8480-401d-8bb5-0726d8195770	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-404-30	21695040430	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP	Rebel Distributors Corp	2010-12-20	HUMAN PRESCRIPTION DRUG LABEL	1