Diltiazem Hydrochloride

Product NDC: 62135-333
11-digit product format: 621350333
Labeler code: 62135
Product ID: 62135-333_1b432d9d-b46c-2ee8-e063-6294a90adb54
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA074093
Marketing category: ANDA
Marketing start: 1992-11-05
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: 2026-12-31
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	Approval date
A074093-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05
A074093-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05
A074093-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05
A074093-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074093-001	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074093-002	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074093-003	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074093-004	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`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: 2026-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
831054	Internal RxNorm lookup
831102	Internal RxNorm lookup
831103	Internal RxNorm lookup
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
51abce7b-e3d1-44b5-bccc-d463150d0bba	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
62135-333-12	Diltiazem Hydrochloride	120 in 1 BOTTLE	TABLET	120		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-333-12	EA - Each	62135-333	87daf11a-b85e-43a7-beba-8509b511f5ee	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-333	DILTIAZEM HYDROCHLORIDE TABLET [CHARTWELL RX, LLC]	1	Current NDC, 1 package rows	20240622_51abce7b-e3d1-44b5-bccc-d463150d0bba.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	Chartwell RX, LLC	51abce7b-e3d1-44b5-bccc-d463150d0bba	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074093 application number: ANDA074093 ndc (product): 62135-333

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
831102	dilTIAZem HCl 90 MG Oral Tablet	PSN	51abce7b-e3d1-44b5-bccc-d463150d0bba	1
831054	dilTIAZem hydrochloride 120 MG Oral Tablet	PSN	51abce7b-e3d1-44b5-bccc-d463150d0bba	1
833217	dilTIAZem hydrochloride 30 MG Oral Tablet	PSN	51abce7b-e3d1-44b5-bccc-d463150d0bba	1
831103	dilTIAZem hydrochloride 60 MG Oral Tablet	PSN	51abce7b-e3d1-44b5-bccc-d463150d0bba	1
831054	diltiazem hydrochloride 120 MG Oral Tablet	SCD	51abce7b-e3d1-44b5-bccc-d463150d0bba	1
833217	diltiazem hydrochloride 30 MG Oral Tablet	SCD	51abce7b-e3d1-44b5-bccc-d463150d0bba	1
831103	diltiazem hydrochloride 60 MG Oral Tablet	SCD	51abce7b-e3d1-44b5-bccc-d463150d0bba	1
831102	diltiazem hydrochloride 90 MG Oral Tablet	SCD	51abce7b-e3d1-44b5-bccc-d463150d0bba	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-333-12	62135033312	120 TABLET in 1 BOTTLE (62135-333-12)	120 tablet	2024-06-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride Tablets, USP Rx only	Chartwell RX, LLC	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	1