Diltiazem Hydrochloride

Product NDC: 70860-301
11-digit product format: 708600301
Labeler code: 70860
Product ID: 70860-301_7fb9b2d0-abc0-4ec5-af4e-9db654c9ae3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diltiazem hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA074617
Marketing category: ANDA
Marketing start: 2019-12-15
Marketing end: 0000-00-00
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 5 mg/mL
Pharmacologic classes: Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70860-301		D	Discontinued by firm	2026-08-03
excluded package	package	70860-301	70860-301-05	D	Discontinued by firm	2026-08-03
excluded package	package	70860-301	70860-301-10	D	Discontinued by firm	2026-08-03
excluded package	package	70860-301	70860-301-25	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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70860-301	70860-301-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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

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 · 41 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
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074617-001	DILTIAZEM HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1996-02-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	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…`
2022-09-29 23:25 UTC	2022-09	A074617-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074617-001	AP	1	`cb3db0bc1861…`

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, Related label table
NDC	Effective	Related label
70860-301-05	2024-03-03	Diltiazem Hydrochloride Injection
70860-301-10	2024-03-03	Diltiazem Hydrochloride Injection
70860-301-25	2024-03-03	Diltiazem Hydrochloride Injection
70860-301-05	2024-01-30	Diltiazem Hydrochloride Injection
70860-301-10	2024-01-30	Diltiazem Hydrochloride Injection
70860-301-25	2024-01-30	Diltiazem Hydrochloride Injection

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-301-05	ML - Milliliter	70860-301	1961b8b0-4637-4622-a0f9-9507ef742d01	1	2020-02-13
70860-301-10	ML - Milliliter	70860-301	10756b5f-9b7b-4622-84d2-b7835632823d	1	2020-03-10
70860-301-25	ML - Milliliter	70860-301	28b5dd64-ed50-4806-b5ad-f398bfe7b262	1	2020-03-10
70860-301-41	ML - Milliliter	70860-301	1cb245a9-a811-4f70-a97c-95a87692e71a	1	2020-03-10
70860-301-42	ML - Milliliter	70860-301	0b8e766b-923a-4a99-92f6-253ce08c0938	1	2020-03-10
70860-301-43	ML - Milliliter	70860-301	a246aa87-af10-45ee-873f-aff41612628f	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70860-301	DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]	4	Legacy NDC	20250130_0f02f0cf-d34c-4870-a293-e996132a5b89.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Sagent Pharmaceuticals	9d51c0f6-26b7-4220-83fb-4e736b289e64	2024-04-08	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	fbd7ee32-fabe-06e7-e053-6294a90a63e0	2
1791229	5 ML diltiazem hydrochloride 5 MG/ML Injection	SCD	fbd7ee32-fabe-06e7-e053-6294a90a63e0	2
1791229	diltiazem hydrochloride 25 MG per 5 ML Injection	SY	fbd7ee32-fabe-06e7-e053-6294a90a63e0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-301-05	70860030105	10 VIAL in 1 CARTON (70860-301-05) > 5 mL in 1 VIAL (70860-301-41)	10 vial	2019-12-15	0000-00-00	No	No	Current
70860-301-10	70860030110	10 VIAL in 1 CARTON (70860-301-10) > 10 mL in 1 VIAL (70860-301-42)	10 vial	2019-12-15	0000-00-00	No	No	Current
70860-301-25	70860030125	10 VIAL in 1 CARTON (70860-301-25) > 25 mL in 1 VIAL (70860-301-43)	10 vial	2019-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride Injection	Athenex Pharmaceutical Division, LLC.	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	4
Diltiazem Hydrochloride Injection	Medical Purchasing Solutions, LLC. \| Medical Purchasing Solutions, LLC	2023-05-16	HUMAN PRESCRIPTION DRUG LABEL	2