Diltiazem Hydrochloride

Product NDC: 71872-7063
Requested package NDC: 71872-7063-1
11-digit product format: 718727063
Labeler code: 71872
Product ID: 71872-7063_fcea91c3-e42b-8991-e053-6394a90a099d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Medical Purchasing Solutions, LLC
Application: ANDA078538
Marketing category: ANDA
Marketing start: 2008-12-17
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
A078538-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP		2008-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078538-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078538-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	2008-12-17	`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	A078538-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078538-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078538-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078538-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078538-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078538-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078538-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078538-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078538-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078538-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078538-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078538-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078538-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078538-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078538-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078538-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078538-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078538-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078538-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078538-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078538-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078538-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078538-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078538-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078538-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078538-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078538-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078538-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078538-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078538-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078538-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078538-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078538-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078538-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078538-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078538-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078538-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078538-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078538-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078538-001	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
9f69371d-3ede-285d-e053-2a95a90a6e42	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
71872-7063-1	Diltiazem Hydrochloride	1 in 1 BAG	INJECTION	1		2
71872-7063-1	Diltiazem Hydrochloride	5 mL in 1 VIAL	INJECTION	5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71872-7063	DILTIAZEM HYDROCHLORIDE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20230531_9f69371d-3ede-285d-e053-2a95a90a6e42.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	734beeef-3968-4137-af2c-276e8a9317df	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078538 application number: ANDA078538
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	453b73bd-c52d-4d72-a0b3-47588e723e0b	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078538 application number: ANDA078538
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9f69371d-3ede-285d-e053-2a95a90a6e42	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078538 application number: ANDA078538 ndc (package): 71872-7063-1 ndc (product): 71872-7063 ndc11 (package): 71872706301
DILTIAZEM HCI	DILTIAZEM HCI	HF Acquisition Co LLC, DBA HealthFirst	7d8e8b1e-f67b-57d2-e053-2991aa0a8d12	2023-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078538 application number: ANDA078538

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	9f69371d-3ede-285d-e053-2a95a90a6e42	2
1791229	5 ML diltiazem hydrochloride 5 MG/ML Injection	SCD	9f69371d-3ede-285d-e053-2a95a90a6e42	2
1791229	diltiazem hydrochloride 25 MG per 5 ML Injection	SY	9f69371d-3ede-285d-e053-2a95a90a6e42	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71872-7063-1	71872706301	1 VIAL in 1 BAG (71872-7063-1) / 5 mL in 1 VIAL	1 vial	2020-01-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride Injection Rx Only	Medical Purchasing Solutions, LLC	2023-05-30	HUMAN PRESCRIPTION DRUG LABEL	2