Diltiazem HCl CD

Product NDC: 71335-2029
Requested package NDC: 71335-2029-1
11-digit product format: 713352029
Labeler code: 71335
Product ID: 71335-2029_fb70027d-afde-4a0b-b0ae-2fa48b48229f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem Hydrochloride
Dosage form: CAPSULE, COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA020062
Marketing category: NDA
Marketing start: 2001-04-11
Marketing end: 0000-00-00
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 360 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-2029	71335-2029-1	D	Discontinued by firm		2026-08-11

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020062-001	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10
N020062-002	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27
N020062-003	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27
N020062-004	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27
N020062-005	CARDIZEM CD	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N020062-001	AB3
N020062-002	AB3
N020062-003	AB3
N020062-004	AB3
N020062-005	AB3

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 6 · 205 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	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-001	CARDIZEM CD	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1992-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-002	CARDIZEM CD	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-003	CARDIZEM CD	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-004	CARDIZEM CD	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	1991-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-005	CARDIZEM CD	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	1999-08-24	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	N020062-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-004	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020062-005	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-004	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020062-005	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020062-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-004	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020062-005	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-004	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020062-005	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-004	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020062-005	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-004	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020062-005	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-004	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020062-005	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-004	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020062-005	AB3	1	`5bbf6a4d5a75…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2029-1	EA - Each	71335-2029	be24b36f-f668-4d07-9f6e-a9790021ddc3	1	2025-07-08
71335-2029-2	EA - Each	71335-2029	d8d2bcba-8d16-4c8c-baec-2ef9e575c504	1	2025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2029	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	101	Legacy NDC	20230609_eef5dc85-5319-4f7e-bc59-659a5c8a95ee.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cardizem CD	DILTIAZEM HYDROCHLORIDE	Bausch Health US LLC	1042fa13-e6af-46b9-8008-6c941f0978b1	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020062 application number: NDA020062

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	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-2029-1	71335202901	30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2029-1)	2022-02-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride CD Extended-Release Capsules	Bryant Ranch Prepack	2023-06-08	HUMAN PRESCRIPTION DRUG LABEL	101