Diltiazem Hydrochloride

Product NDC: 24979-183
11-digit product format: 249790183
Labeler code: 24979
Product ID: 24979-183_515b321d-2983-49dd-bccd-4e4e375e33c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diltiazem hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA217377
Marketing category: ANDA
Marketing start: 2023-05-01
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 120 mg/1
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A217377-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01
A217377-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01
A217377-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A217377-001	AB1
A217377-002	AB1
A217377-003	AB1

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 · 69 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
2026-02-19 14:30 UTC	2026-02	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217377-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217377-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217377-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 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	A217377-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217377-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217377-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217377-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217377-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217377-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217377-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217377-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217377-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217377-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217377-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217377-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217377-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217377-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217377-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217377-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217377-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217377-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217377-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217377-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217377-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217377-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217377-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217377-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217377-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217377-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217377-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217377-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217377-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217377-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217377-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217377-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217377-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217377-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217377-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217377-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217377-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217377-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217377-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217377-001	AB1	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diltiazem Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DILTIAZEM HYDROCHLORIDE	120 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
830865	Internal RxNorm lookup
830869	Internal RxNorm lookup
830872	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
f276d9fe-a685-4d99-ad82-d4452ef4ba98	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
24979-183-01	Diltiazem Hydrochloride	100 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24979-183-01	EA - Each	24979-183	de8365e5-a9d0-4432-8d37-d8a774c385d9	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24979-183	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]	9	Current NDC, 1 package rows	20250410_f276d9fe-a685-4d99-ad82-d4452ef4ba98.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
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	f276d9fe-a685-4d99-ad82-d4452ef4ba98	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217377 application number: ANDA217377 ndc (product): 24979-183

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
830872	dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral Capsule	PSN	f276d9fe-a685-4d99-ad82-d4452ef4ba98	10
830865	dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral Capsule	PSN	f276d9fe-a685-4d99-ad82-d4452ef4ba98	10
830869	dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral Capsule	PSN	f276d9fe-a685-4d99-ad82-d4452ef4ba98	10
830872	12 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	f276d9fe-a685-4d99-ad82-d4452ef4ba98	10
830865	12 HR diltiazem hydrochloride 60 MG Extended Release Oral Capsule	SCD	f276d9fe-a685-4d99-ad82-d4452ef4ba98	10
830869	12 HR diltiazem hydrochloride 90 MG Extended Release Oral Capsule	SCD	f276d9fe-a685-4d99-ad82-d4452ef4ba98	10
830872	diltiazem hydrochloride 120 MG 12 HR Extended Release Oral Capsule	SY	f276d9fe-a685-4d99-ad82-d4452ef4ba98	10
830865	diltiazem hydrochloride 60 MG 12 HR Extended Release Oral Capsule	SY	f276d9fe-a685-4d99-ad82-d4452ef4ba98	10
830869	diltiazem hydrochloride 90 MG 12 HR Extended Release Oral Capsule	SY	f276d9fe-a685-4d99-ad82-d4452ef4ba98	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
24979-183-01	24979018301	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24979-183-01)	2023-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride	Upsher-Smith Laboratories, LLC \| TWi Pharmaceuticals, Inc. \| Bora Pharmaceutical Laboratories Inc. Zhongli Plant \| BORA PHARMACEUTICAL LABORATORIES INC.	2026-05-08	HUMAN PRESCRIPTION DRUG LABEL	10