TIAZAC

Product NDC: 0187-2616
11-digit product format: 001872616
Labeler code: 0187
Product ID: 0187-2616_fe0721cb-5bee-49c5-909b-3c7ea0e2e6c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diltiazem hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Bausch Health US, LLC
Application: NDA020401
Marketing category: NDA
Marketing start: 2014-08-20
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 360 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020401-001	TIAZAC	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-002	TIAZAC	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-003	TIAZAC	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-004	TIAZAC	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-005	TIAZAC	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11
N020401-006	TIAZAC	DILTIAZEM HYDROCHLORIDE	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N020401-001	AB4
N020401-002	AB4
N020401-003	AB4
N020401-004	AB4
N020401-005	AB4
N020401-006	AB4

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 7 · 246 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	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-005	TIAZAC	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-006	TIAZAC	420MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD, RS	1998-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-001	TIAZAC	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-002	TIAZAC	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-003	TIAZAC	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-004	TIAZAC	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB4	RLD	1995-09-11	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	N020401-001	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-002	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-003	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-004	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-005	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020401-006	AB4	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-001	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-002	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-003	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-004	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-005	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020401-006	AB4	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020401-001	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-002	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-003	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-004	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-005	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020401-006	AB4	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-001	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-002	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-003	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-004	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-005	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020401-006	AB4	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-001	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-002	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-003	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-004	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-005	AB4	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020401-006	AB4	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-001	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-002	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-003	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-004	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-005	AB4	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020401-006	AB4	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-001	AB4	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-002	AB4	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-003	AB4	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020401-004	AB4	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: TIAZAC
Brand name suffix: EXTENDED RELEASE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DILTIAZEM HYDROCHLORIDE	360 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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c567fe7e-887e-4291-a0d1-2dd3f25cbf25	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
0187-2616-30	TIAZACEXTENDED RELEASE	30 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	30		11
0187-2616-90	TIAZACEXTENDED RELEASE	90 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	90		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-2616-30	EA - Each	0187-2616	5938e311-f21a-42bf-b530-d01884be985a	1	2014-10-03
0187-2616-90	EA - Each	0187-2616	e6c18e77-4110-4b98-ae7b-da47eae8b2b8	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
diltiazem hydrochloride	ACTIVE INGREDIENT	OLH94387TE	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Diltiazem	ACTIVE MOIETY	EE92BBP03H	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
D&C Red No. 28	INACTIVE INGREDIENT	767IP0Y5NH	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1; 750000 MW)	INACTIVE INGREDIENT	P2OM2Q86BI	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
FD&C Green No. 3	INACTIVE INGREDIENT	3P3ONR6O1S	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
sucrose stearate	INACTIVE INGREDIENT	274KW0O50M	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-2616	TIAZAC EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BAUSCH HEALTH US, LLC]	10	Current NDC, Legacy NDC, 2 package rows	20250427_c567fe7e-887e-4291-a0d1-2dd3f25cbf25.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TIAZAC EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bausch Health US, LLC	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401 ndc (product): 0187-2616
Diltiazem Hydrochloride EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	58eeb8bc-91d0-4cf8-a0d7-be3548d92196	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Oceanside Pharmaceuticals	862d65cb-a732-4786-b569-bad2eaafddfd	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	c7c6a74e-5f73-4265-a0e0-8fd2cd26909e	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401
DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE	direct rx	c7cf9276-4b4c-10b2-e053-2995a90a3738	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020401 application number: NDA020401

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	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830845	dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule	PSN	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830837	dilTIAZem HCl 240 MG 24HR Extended Release Oral Capsule	PSN	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830801	dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral Capsule	PSN	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830795	dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral Capsule	PSN	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831359	dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral Capsule	PSN	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831193	Tiazac 120 MG 24HR Extended Release Oral Capsule	PSN	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831244	Tiazac 180 MG 24HR Extended Release Oral Capsule	PSN	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831296	Tiazac 240 MG 24HR Extended Release Oral Capsule	PSN	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831323	Tiazac 300 MG 24HR Extended Release Oral Capsule	PSN	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831347	Tiazac 360 MG 24HR Extended Release Oral Capsule	PSN	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831360	Tiazac 420 MG 24HR Extended Release Oral Capsule	PSN	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831193	24 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule [Tiazac]	SBD	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831244	24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule [Tiazac]	SBD	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831296	24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule [Tiazac]	SBD	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831323	24 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule [Tiazac]	SBD	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831347	24 HR diltiazem hydrochloride 360 MG Extended Release Oral Capsule [Tiazac]	SBD	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831360	24 HR diltiazem hydrochloride 420 MG Extended Release Oral Capsule [Tiazac]	SBD	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830861	24 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830845	24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule	SCD	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830837	24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule	SCD	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830801	24 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule	SCD	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830795	24 HR diltiazem hydrochloride 360 MG Extended Release Oral Capsule	SCD	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831359	24 HR diltiazem hydrochloride 420 MG Extended Release Oral Capsule	SCD	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831193	24 HR Tiazac 120 MG Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831244	24 HR Tiazac 180 MG Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831296	24 HR Tiazac 240 MG Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831323	24 HR Tiazac 300 MG Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831347	24 HR Tiazac 360 MG Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830861	diltiazem HCl 120 MG 24 HR Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830845	diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830837	diltiazem HCl 240 MG 24 HR Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830801	diltiazem hydrochloride 300 MG 24 HR Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
830795	diltiazem hydrochloride 360 MG 24 HR Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831359	diltiazem hydrochloride 420 MG 24 HR Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831193	Tiazac 120 MG 24 HR Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831244	Tiazac 180 MG 24 HR Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831296	Tiazac 240 MG 24 HR Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831323	Tiazac 300 MG 24 HR Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831347	Tiazac 360 MG 24 HR Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11
831360	Tiazac 420 MG 24 HR Extended Release Oral Capsule	SY	c567fe7e-887e-4291-a0d1-2dd3f25cbf25	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-2616-30	00187261630	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2616-30)	2014-08-20	0000-00-00	No	No	Current
0187-2616-90	00187261690	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2616-90)	2014-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tiazac ® (diltiazem hydrochloride) Extended-Release Capsules, USP	Bausch Health US, LLC \| Bausch Health Companies, Inc.	2026-08-07	HUMAN PRESCRIPTION DRUG LABEL	12