Diltiazem Hydrochloride

Product NDC: 71335-2373
11-digit product format: 713352373
Labeler code: 71335
Product ID: 71335-2373_020ff431-ae7c-417e-866e-86ba89bb696b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA216521
Marketing category: ANDA
Marketing start: 2022-09-26
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A216521-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23
A216521-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23
A216521-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23
A216521-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216521-001	AB
A216521-002	AB
A216521-003	AB
A216521-004	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 3 · 112 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
2026-09-14 22:38:34	2026-08	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2022-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2022-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	AB	2022-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2022-09-23	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216521-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216521-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216521-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216521-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216521-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216521-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216521-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216521-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216521-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216521-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216521-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216521-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216521-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216521-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216521-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216521-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216521-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216521-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216521-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216521-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216521-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216521-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	30 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
833217	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
76e04232-b3da-48e8-a944-5f4f97a508df	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
71335-2373-1	Diltiazem Hydrochloride	90 in 1 BOTTLE	TABLET	90		101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2373	DILTIAZEM HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	100	Current NDC, 1 package rows	20240525_76e04232-b3da-48e8-a944-5f4f97a508df.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	50df9f09-aa2f-495d-a25c-7c5c0fdffcf0	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	76e04232-b3da-48e8-a944-5f4f97a508df	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521 ndc (product): 71335-2373
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Northwind Health Company, LLC	106b33e3-b199-e555-e063-6294a90a5af5	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Northwind Health Company, LLC	09a5d332-347b-e73d-e063-6294a90a67ed	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc	196fc367-330e-4d15-b1d6-084ad3f97ae7	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Coupler LLC	3418eb02-117e-a71a-e063-6394a90a826e	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Coupler LLC	2cd92b83-075e-b069-e063-6294a90a9fff	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	88b150a6-4c8d-49c8-88df-f3606c335472	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216521 application number: ANDA216521

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
833217	dilTIAZem hydrochloride 30 MG Oral Tablet	PSN	76e04232-b3da-48e8-a944-5f4f97a508df	101
833217	diltiazem hydrochloride 30 MG Oral Tablet	SCD	76e04232-b3da-48e8-a944-5f4f97a508df	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2373-1	71335237301	90 TABLET in 1 BOTTLE (71335-2373-1)	90 tablet	2024-05-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride Tablets, USP Tablets	Bryant Ranch Prepack	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	101