Diltiazem Hydrochloride

Product NDC: 70934-854
11-digit product format: 709340854
Labeler code: 70934
Product ID: 70934-854_c0e08abf-3354-835a-e053-2a95a90a0f97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: NDA018602
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2021-04-23
Marketing end: 0000-00-00
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 60 mg/1
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	70934-854		D	Discontinued by firm		2026-08-11
excluded package	package	70934-854	70934-854-30	D	Discontinued by firm		2026-08-11

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-854-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-854-30	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018602-001	CARDIZEM	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	RLD	1982-11-05
N018602-002	CARDIZEM	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	RLD	1982-11-05
N018602-003	CARDIZEM	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	RLD	1986-12-08
N018602-004	CARDIZEM	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	RLD, RS	1986-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N018602-001	AB
N018602-002	AB
N018602-003	AB
N018602-004	AB

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 5 · 164 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	N018602-001	CARDIZEM	30MG	TABLET / ORAL	AB	RLD	1982-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018602-002	CARDIZEM	60MG	TABLET / ORAL	AB	RLD	1982-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018602-003	CARDIZEM	90MG	TABLET / ORAL	AB	RLD	1986-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018602-004	CARDIZEM	120MG	TABLET / ORAL	AB	RLD, RS	1986-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018602-001	CARDIZEM	30MG	TABLET / ORAL	AB	RLD	1982-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018602-002	CARDIZEM	60MG	TABLET / ORAL	AB	RLD	1982-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018602-003	CARDIZEM	90MG	TABLET / ORAL	AB	RLD	1986-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018602-004	CARDIZEM	120MG	TABLET / ORAL	AB	RLD, RS	1986-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018602-001	CARDIZEM	30MG	TABLET / ORAL	AB	RLD	1982-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018602-002	CARDIZEM	60MG	TABLET / ORAL	AB	RLD	1982-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018602-003	CARDIZEM	90MG	TABLET / ORAL	AB	RLD	1986-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018602-004	CARDIZEM	120MG	TABLET / ORAL	AB	RLD, RS	1986-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018602-001	CARDIZEM	30MG	TABLET / ORAL	AB	RLD	1982-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018602-002	CARDIZEM	60MG	TABLET / ORAL	AB	RLD	1982-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018602-003	CARDIZEM	90MG	TABLET / ORAL	AB	RLD	1986-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018602-004	CARDIZEM	120MG	TABLET / ORAL	AB	RLD, RS	1986-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018602-001	CARDIZEM	30MG	TABLET / ORAL	AB	RLD	1982-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018602-002	CARDIZEM	60MG	TABLET / ORAL	AB	RLD	1982-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018602-003	CARDIZEM	90MG	TABLET / ORAL	AB	RLD	1986-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018602-004	CARDIZEM	120MG	TABLET / ORAL	AB	RLD, RS	1986-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018602-001	CARDIZEM	30MG	TABLET / ORAL	AB	RLD	1982-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018602-002	CARDIZEM	60MG	TABLET / ORAL	AB	RLD	1982-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018602-003	CARDIZEM	90MG	TABLET / ORAL	AB	RLD	1986-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018602-004	CARDIZEM	120MG	TABLET / ORAL	AB	RLD, RS	1986-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018602-001	CARDIZEM	30MG	TABLET / ORAL	AB	RLD	1982-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018602-002	CARDIZEM	60MG	TABLET / ORAL	AB	RLD	1982-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018602-003	CARDIZEM	90MG	TABLET / ORAL	AB	RLD	1986-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018602-004	CARDIZEM	120MG	TABLET / ORAL	AB	RLD, RS	1986-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018602-001	CARDIZEM	30MG	TABLET / ORAL	AB	RLD	1982-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018602-002	CARDIZEM	60MG	TABLET / ORAL	AB	RLD	1982-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018602-003	CARDIZEM	90MG	TABLET / ORAL	AB	RLD	1986-12-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018602-004	CARDIZEM	120MG	TABLET / ORAL	AB	RLD, RS	1986-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018602-001	CARDIZEM	30MG	TABLET / ORAL	AB	RLD	1982-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018602-002	CARDIZEM	60MG	TABLET / ORAL	AB	RLD	1982-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018602-003	CARDIZEM	90MG	TABLET / ORAL	AB	RLD	1986-12-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018602-004	CARDIZEM	120MG	TABLET / ORAL	AB	RLD, RS	1986-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018602-001	CARDIZEM	30MG	TABLET / ORAL	AB	RLD	1982-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018602-002	CARDIZEM	60MG	TABLET / ORAL	AB	RLD	1982-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018602-003	CARDIZEM	90MG	TABLET / ORAL	AB	RLD	1986-12-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018602-004	CARDIZEM	120MG	TABLET / ORAL	AB	RLD, RS	1986-12-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	N018602-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018602-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018602-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018602-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018602-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018602-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018602-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018602-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018602-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018602-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018602-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018602-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018602-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018602-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018602-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018602-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018602-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018602-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018602-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018602-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018602-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018602-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018602-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018602-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018602-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018602-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018602-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018602-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018602-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018602-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018602-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018602-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018602-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018602-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018602-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018602-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018602-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018602-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018602-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018602-004	AB	1	`d06236e962d9…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-854	DILTIAZEM HYDROCHLORIDE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	2	Legacy NDC	20230120_c0e06da3-3d94-12a8-e053-2a95a90a6835.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
Cardizem	DILTIAZEM HYDROCHLORIDE	Bausch Health US LLC	f3e7ecef-f360-4987-a4f5-933214130ab2	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018602 application number: NDA018602
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	636556f6-2987-984f-e053-2991aa0a201a	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018602 application number: NDA018602
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	225a87fb-d353-4ee7-bd08-14d631ff6b16	2023-06-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018602 application number: NDA018602
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Oceanside Pharmaceuticals	f6a24de7-8ffe-48af-873f-10fdcd5551d1	2020-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018602 application number: NDA018602

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
70934-854-30	70934085430	30 TABLET in 1 BOTTLE, PLASTIC (70934-854-30)	30 tablet	2021-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride Tablets	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-05	HUMAN PRESCRIPTION DRUG LABEL	2