DILTIAZEM HYDROCHLORIDE

Product NDC: 51754-3000
11-digit product format: 517543000
Labeler code: 51754
Product ID: 51754-3000_8380def7-7f6c-48f1-84ba-935077479130
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diltiazem hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Exela Pharma Sciences,LLC
Application: NDA215252
Marketing category: NDA
Marketing start: 2021-11-30
Marketing end: 0000-00-00
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	51754-3000		D	Discontinued by firm		2026-08-03
excluded package	package	51754-3000	51754-3000-3	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 · 18 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	51754-3000-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51754-3000-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51754-3000-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51754-3000-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51754-3000-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51754-3000-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51754-3000-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51754-3000-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51754-3000-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

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 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2021-12-28 21:50 UTC	2021-12	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-10-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-10-28	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215252-001	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	125MG/125ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215252-002	DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%	250MG/250ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2021-10-28	`6a51e52b5d6a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51754-3000-3	2025-12-03	C162847	48780-1	2cef2736-8a60-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use DILTIAZEM HYDROCHLORIDE IN DEXTROSE INJECTION safely and effectively. See full prescribing information for DILTIAZEM HYDROCHLORIDE IN DEXTROSE INJECTION. DILTIAZEM HYDROCHLORIDE IN DEXTROSE injection, for intravenous use only Initial U.S. Approval: 1982
51754-3000-3	2025-01-30	C162847	48780-1	2cef2736-8a60-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use DILTIAZEM HYDROCHLORIDE IN DEXTROSE INJECTION safely and effectively. See full prescribing information for DILTIAZEM HYDROCHLORIDE IN DEXTROSE INJECTION. DILTIAZEM HYDROCHLORIDE IN DEXTROSE injection, for intravenous use only Initial U.S. Approval: 1982

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51754-3000	DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [EXELA PHARMA SCIENCES,LLC]	1	Legacy NDC	20211130_51ddc49b-f2b5-4e79-93f5-e236fb546a66.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OLH94387TE	DILTIAZEM HYDROCHLORIDE	33286-22-5	DILTIAZEM HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51754-3000-3	51754300003	10 BAG in 1 CARTON (51754-3000-3) > 125 mL in 1 BAG	10 bag	2021-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DILTIAZEM HYDROCHLORIDE	Exela Pharma Sciences,LLC \| Exela Pharma Sceinces, LLC	2021-11-30	HUMAN PRESCRIPTION DRUG LABEL	1