diltiazem hydrochloride

Product NDC: 50742-251
11-digit product format: 507420251
Labeler code: 50742
Product ID: 50742-251_d52d40db-f91a-49ea-ac2f-88a56f429421
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diltiazem hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA208783
Marketing category: ANDA
Marketing start: 2019-06-14
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 300 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208783-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14
A208783-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14
A208783-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14
A208783-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14
A208783-005	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208783-001	AB3
A208783-002	AB3
A208783-003	AB3
A208783-004	AB3
A208783-005	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208783-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208783-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208783-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208783-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208783-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208783-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208783-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208783-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208783-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208783-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208783-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208783-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208783-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208783-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208783-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208783-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208783-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208783-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208783-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208783-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208783-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208783-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208783-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208783-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208783-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208783-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208783-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208783-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208783-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208783-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208783-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208783-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208783-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208783-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208783-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208783-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208783-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208783-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208783-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208783-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2019-06-14	`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	A208783-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208783-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208783-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208783-004	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208783-005	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208783-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208783-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208783-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208783-004	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208783-005	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208783-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208783-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208783-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208783-004	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208783-005	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208783-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208783-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208783-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208783-004	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208783-005	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208783-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208783-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208783-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208783-004	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208783-005	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208783-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208783-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208783-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208783-004	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208783-005	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208783-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208783-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208783-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208783-004	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208783-005	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208783-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208783-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208783-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208783-004	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208783-005	AB3	1	`5bbf6a4d5a75…`

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	300 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
830795	Internal RxNorm lookup
830801	Internal RxNorm lookup
830837	Internal RxNorm lookup
830845	Internal RxNorm lookup
830861	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
355f560a-8ebb-4661-ad74-2a22f707d7f8	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	SPL version
50742-251-05	diltiazem hydrochloride	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500	6
50742-251-10	diltiazem hydrochloride	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000	6
50742-251-30	diltiazem hydrochloride	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	6
50742-251-90	diltiazem hydrochloride	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-251-30	EA - Each	50742-251	b67a82d7-2555-4c17-b36e-221f1130d2a5	1	2020-09-14
50742-251-90	EA - Each	50742-251	21dba915-281a-4b10-91d3-16940a945702	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-251	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]	5	Current NDC, Legacy NDC, 4 package rows	20231030_355f560a-8ebb-4661-ad74-2a22f707d7f8.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 · 10 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	ec928ee5-0809-4ba5-82ca-ecfed99ebb5a	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208783 application number: ANDA208783
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	REMEDYREPACK INC.	5e935265-d0fc-4223-835f-72426eeea6c4	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208783 application number: ANDA208783
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3d594530-885f-45c7-b8a5-fd7e503ff83f	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208783 application number: ANDA208783
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	a469b24a-fbec-4a2d-8b4c-b62c2b2c66f6	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208783 application number: ANDA208783
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	e6d9397c-f8a2-42d6-88ca-55060b1d073a	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208783 application number: ANDA208783
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	9041cc05-29d2-41ca-a368-e953bf3443b5	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208783 application number: ANDA208783
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	0089fc7a-a7aa-4873-b699-39a1b21616ca	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208783 application number: ANDA208783
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	355f560a-8ebb-4661-ad74-2a22f707d7f8	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208783 application number: ANDA208783 ndc (product): 50742-251
Diltiazem HCL ER	DILTIAZEM HCL ER	Direct_Rx	f1ea85b2-ecd2-5867-e053-2a95a90a24dc	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208783 application number: ANDA208783
diltiazem hydrochloride	DILTIAZEM HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	70f167a1-ec7f-4969-b446-166af3e52c05	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208783 application number: ANDA208783

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
830861	dilTIAZem HCl 120 MG 24HR Extended Release Oral Capsule	PSN	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830845	dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule	PSN	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830837	dilTIAZem HCl 240 MG 24HR Extended Release Oral Capsule	PSN	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830801	dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral Capsule	PSN	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830795	dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral Capsule	PSN	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830861	24 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830845	24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule	SCD	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830837	24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule	SCD	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830801	24 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule	SCD	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830795	24 HR diltiazem hydrochloride 360 MG Extended Release Oral Capsule	SCD	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830861	diltiazem HCl 120 MG 24 HR Extended Release Oral Capsule	SY	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830845	diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule	SY	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830837	diltiazem HCl 240 MG 24 HR Extended Release Oral Capsule	SY	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830801	diltiazem hydrochloride 300 MG 24 HR Extended Release Oral Capsule	SY	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830795	diltiazem hydrochloride 360 MG 24 HR Extended Release Oral Capsule	SY	355f560a-8ebb-4661-ad74-2a22f707d7f8	6
830801	dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral Capsule	PSN	f1ea85b2-ecd2-5867-e053-2a95a90a24dc	3
830801	24 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule	SCD	f1ea85b2-ecd2-5867-e053-2a95a90a24dc	3
830801	diltiazem hydrochloride 300 MG 24 HR Extended Release Oral Capsule	SY	f1ea85b2-ecd2-5867-e053-2a95a90a24dc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-251-05	50742025105	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-05)	2019-06-14	0000-00-00	No	No	Current
50742-251-10	50742025110	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-10)	2019-06-14	0000-00-00	No	No	Current
50742-251-30	50742025130	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-30)	2019-06-14	0000-00-00	No	No	Current
50742-251-90	50742025190	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-90)	2019-06-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride Extended-Release Capsules, USP	Ingenus Pharmaceuticals, LLC \| Novast Laboratories, Ltd.	2025-06-17	HUMAN PRESCRIPTION DRUG LABEL	6
Diltiazem HCL ER	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	3