Diltiazem HCl CD

Product NDC: 68682-521
11-digit product format: 686820521
Labeler code: 68682
Product ID: 68682-521_d6cc69c3-44a9-43e4-9b6a-2851c2e16b15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem Hydrochloride
Dosage form: CAPSULE, COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Oceanside Pharmaceuticals
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68682-521		D	Discontinued by firm		2026-08-11
excluded package	package	68682-521	68682-521-01	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 · 2 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 product	product	68682-521		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68682-521	68682-521-01	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 · 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 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-521-01	EA - Each	68682-521	b24c1fbb-d565-456c-8c51-c5838126dc8a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diltiazem Hydrochloride	ACTIVE INGREDIENT	OLH94387TE	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
Diltiazem	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
acetyltributyl citrate	INACTIVE INGREDIENT	0ZBX0N59RZ	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
AMMONIO METHACRYLATE COPOLYMER TYPE A	INACTIVE INGREDIENT	8GQS4E66YY	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
AMMONIO METHACRYLATE COPOLYMER TYPE B	INACTIVE INGREDIENT	161H3B14U2	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
diethyl phthalate	INACTIVE INGREDIENT	UF064M00AF	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
gelatin	INACTIVE INGREDIENT	2G86QN327L	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
sucrose	INACTIVE INGREDIENT	C151H8M554	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-521	DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	10	Legacy NDC	20200625_5e39be50-ea17-4077-a2dc-668267049f6a.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
68682-521-01	68682052101	90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68682-521-01)	2016-06-30	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
Diltiazem Hydrochloride CD Extended-Release Capsules	Oceanside Pharmaceuticals \| Bausch Health Companies, Inc.	2020-04-01	HUMAN PRESCRIPTION DRUG LABEL	11