Diltiazem Hydrochloride

Product NDC: 71872-7345
Requested package NDC: 71872-7345-1
11-digit product format: 718727345
Labeler code: 71872
Product ID: 71872-7345_41d74885-4313-bdcd-e063-6394a90aea00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diltiazem hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Medical Purchasing Solutions, LLC
Application: ANDA074617
Marketing category: ANDA
Marketing start: 2024-06-01
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 5 mg/mL
Pharmacologic classes: Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074617-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074617-001	AP

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A074617-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074617-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074617-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074617-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074617-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074617-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074617-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074617-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074617-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074617-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074617-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074617-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074617-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074617-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074617-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074617-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074617-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074617-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074617-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074617-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074617-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074617-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074617-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074617-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074617-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074617-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074617-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074617-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074617-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074617-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074617-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074617-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074617-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074617-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074617-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074617-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074617-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074617-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074617-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074617-001	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Diltiazem Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DILTIAZEM HYDROCHLORIDE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
OLH94387TE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1791229	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
41d75325-d935-ba54-e063-6394a90aade2	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71872-7345-1	Diltiazem Hydrochloride	1 in 1 BAG	INJECTION, SOLUTION	1		1
71872-7345-1	Diltiazem Hydrochloride	5 mL in 1 VIAL	INJECTION, SOLUTION	5		1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	HF Acquisition Co. LLC DBA HealthFirst	59464700-f7f1-6ab0-e063-6394a90aa778	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074617 application number: ANDA074617
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Sagent Pharmaceuticals	9d51c0f6-26b7-4220-83fb-4e736b289e64	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074617 application number: ANDA074617
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Medical Purchasing Solutions, LLC	41d75325-d935-ba54-e063-6394a90aade2	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074617 application number: ANDA074617 ndc (package): 71872-7345-1 ndc (product): 71872-7345 ndc11 (package): 71872734501
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	ProPharma Distribution	3f2942d7-f4d0-2d77-e063-6294a90a74ad	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074617 application number: ANDA074617

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
1791229	dilTIAZem hydrochloride 25 MG in 5 mL Injection	PSN	41d75325-d935-ba54-e063-6394a90aade2	1
1791229	5 ML diltiazem hydrochloride 5 MG/ML Injection	SCD	41d75325-d935-ba54-e063-6394a90aade2	1
1791229	diltiazem hydrochloride 25 MG per 5 ML Injection	SY	41d75325-d935-ba54-e063-6394a90aade2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71872-7345-1	71872734501	1 VIAL in 1 BAG (71872-7345-1) / 5 mL in 1 VIAL	1 vial	2025-03-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride Injection	Medical Purchasing Solutions, LLC \| Medical Purchasing Solutions, LLC.	2025-10-23	HUMAN PRESCRIPTION DRUG LABEL	1