Application 215252

Type: NDA
Sponsor: EXELA PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	SOLUTION;INTRAVENOUS	125MG/125ML (1MG/ML)	No	No
002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	SOLUTION;INTRAVENOUS	250MG/250ML (1MG/1ML)	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	DILTIAZEM HYDROCHLORIDE	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2021-10-28
N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	DILTIAZEM HYDROCHLORIDE	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2021-10-28

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 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-10-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-10-28	`bb7c543d1eb4…`

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 4 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	355f560a-8ebb-4661-ad74-2a22f707d7f8	2025-06-17	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
TIADYLT ER	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	b4b4e53e-fc99-4f34-abc2-57e4f28aff84	2025-06-13	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	c044f774-783f-4920-a8a1-6d4b1b3820c1	2025-06-11	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Cartia XT	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	de671934-25a8-4df6-b7a1-97e0337e9e2b	2025-06-02	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	69ca7cae-fdf3-413a-900b-95cf6e9e7b63	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	976d9dd0-4f11-4439-b84e-0c0f0e018d8b	2025-05-22	Warnings, Adverse reactions	Name fallback brand name: Diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Viona Pharmaceuticals Inc	43cffe12-304a-4e15-9512-94f812188f1a	2025-05-05	Warnings, Adverse reactions	Name fallback brand name: Diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
TIADYLT ER	DILTIAZEM HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	1278cd76-b8e9-42d9-ad19-6858e72cf9f2	2025-05-02	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
TIADYLT ER	DILTIAZEM HYDROCHLORIDE	Zydus Lifesciences Limited	d88e3546-3984-4dc9-893a-a29e95804550	2025-05-02	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Coupler LLC	3418eb02-117e-a71a-e063-6394a90a826e	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	1e2f2025-0350-40c4-ab42-3b57f3d105a6	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Actavis Pharma, Inc.	178eec1f-1d4d-4a38-b66a-d3ba3de06c3d	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Zydus Lifesciences Limited	fe790439-85d4-4cd8-a385-149ea3442a38	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: diltiazem hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Cardizem	DILTIAZEM HYDROCHLORIDE	Bausch Health US LLC	f3e7ecef-f360-4987-a4f5-933214130ab2	2025-04-30	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	64401d2a-bd5b-43fd-879a-e9d16345e827	2025-04-17	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	AvKARE	31e63a95-9e62-01c8-e063-6294a90af0e1	2025-04-03	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS	Oceanside Pharmaceuticals	73b3607a-99d0-44d8-92ef-0074684c9d7d	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride
Cartia XT	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	e02f5fad-6482-4d5d-91c5-0ae6b0ce15b8	2025-03-06	Warnings, Adverse reactions	Name fallback generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Coupler LLC	2ced821f-19a6-4c7e-e063-6394a90adb80	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Coupler LLC	2cd92b83-075e-b069-e063-6294a90a9fff	2025-01-29	Warnings, Adverse reactions	Name fallback brand name: Diltiazem Hydrochloride generic name: DILTIAZEM HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51754-3000	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	Exela Pharma Sciences,LLC	NDA	Current
51754-3500	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	Exela Pharma Sciences,LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71706	ORIG	2022-08-04
69159	ORIG	2021-10-29
69156	ORIG	2021-10-29