Diltiazem Hydrochloride

Product NDC: 0378-6120
11-digit product format: 003786120
Labeler code: 0378
Product ID: 0378-6120_17bfacaf-75db-4179-9a06-244e94a28554
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diltiazem hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA074910
Marketing category: ANDA
Marketing start: 1997-05-02
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: 2027-12-31
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	RLD / RS	Approval date
A074910-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02
A074910-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02
A074910-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074910-001	AB1
A074910-002	AB1
A074910-003	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 4 · 123 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	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RS	1997-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074910-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1		1997-05-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 109 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	A074910-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074910-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074910-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074910-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074910-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074910-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074910-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074910-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074910-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074910-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074910-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074910-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074910-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074910-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074910-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074910-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074910-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074910-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074910-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074910-001	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
ec7e93b8-666c-4d2f-8d08-07931e09f748	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
0378-6120-01	Diltiazem Hydrochloride	100 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-6120-01	EA - Each	0378-6120	4a515741-a740-4ce1-a8c4-842421d6fe19	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DILTIAZEM HYDROCHLORIDE	ACTIVE INGREDIENT	OLH94387TE	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
DILTIAZEM	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	INACTIVE INGREDIENT	5KY68S2577	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	4
DILTIAZEM HYDROCHLORIDE	ACTIVE INGREDIENT	OLH94387TE	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
DILTIAZEM	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	INACTIVE INGREDIENT	5KY68S2577	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-6120	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	11	Current NDC, Legacy NDC, 1 package rows	20250130_ec7e93b8-666c-4d2f-8d08-07931e09f748.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Safecor Health LLC	fc02db0f-5311-4b61-896e-bfe340832735	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074910 application number: ANDA074910
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	ec7e93b8-666c-4d2f-8d08-07931e09f748	2025-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074910 application number: ANDA074910 ndc (product): 0378-6120
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Mylan Institutional Inc.	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074910 application number: ANDA074910
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Coupler LLC	2ced821f-19a6-4c7e-e063-6394a90adb80	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074910 application number: ANDA074910

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	ec7e93b8-666c-4d2f-8d08-07931e09f748	13
830865	dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral Capsule	PSN	ec7e93b8-666c-4d2f-8d08-07931e09f748	13
830869	dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral Capsule	PSN	ec7e93b8-666c-4d2f-8d08-07931e09f748	13
830872	12 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	ec7e93b8-666c-4d2f-8d08-07931e09f748	13
830865	12 HR diltiazem hydrochloride 60 MG Extended Release Oral Capsule	SCD	ec7e93b8-666c-4d2f-8d08-07931e09f748	13
830869	12 HR diltiazem hydrochloride 90 MG Extended Release Oral Capsule	SCD	ec7e93b8-666c-4d2f-8d08-07931e09f748	13
830872	diltiazem hydrochloride 120 MG 12 HR Extended Release Oral Capsule	SY	ec7e93b8-666c-4d2f-8d08-07931e09f748	13
830865	diltiazem hydrochloride 60 MG 12 HR Extended Release Oral Capsule	SY	ec7e93b8-666c-4d2f-8d08-07931e09f748	13
830869	diltiazem hydrochloride 90 MG 12 HR Extended Release Oral Capsule	SY	ec7e93b8-666c-4d2f-8d08-07931e09f748	13
830872	dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral Capsule	PSN	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	10
830865	dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral Capsule	PSN	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	10
830869	dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral Capsule	PSN	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	10
830872	12 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	10
830865	12 HR diltiazem hydrochloride 60 MG Extended Release Oral Capsule	SCD	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	10
830869	12 HR diltiazem hydrochloride 90 MG Extended Release Oral Capsule	SCD	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	10
830872	diltiazem hydrochloride 120 MG 12 HR Extended Release Oral Capsule	SY	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	10
830865	diltiazem hydrochloride 60 MG 12 HR Extended Release Oral Capsule	SY	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	10
830869	diltiazem hydrochloride 90 MG 12 HR Extended Release Oral Capsule	SY	9942f1a2-f66d-4d9e-9794-49bee8abf5ab	10
830872	dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral Capsule	PSN	fc02db0f-5311-4b61-896e-bfe340832735	2
830865	dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral Capsule	PSN	fc02db0f-5311-4b61-896e-bfe340832735	2
830869	dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral Capsule	PSN	fc02db0f-5311-4b61-896e-bfe340832735	2
830872	12 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	fc02db0f-5311-4b61-896e-bfe340832735	2
830865	12 HR diltiazem hydrochloride 60 MG Extended Release Oral Capsule	SCD	fc02db0f-5311-4b61-896e-bfe340832735	2
830869	12 HR diltiazem hydrochloride 90 MG Extended Release Oral Capsule	SCD	fc02db0f-5311-4b61-896e-bfe340832735	2
830872	diltiazem hydrochloride 120 MG 12 HR Extended Release Oral Capsule	SY	fc02db0f-5311-4b61-896e-bfe340832735	2
830865	diltiazem hydrochloride 60 MG 12 HR Extended Release Oral Capsule	SY	fc02db0f-5311-4b61-896e-bfe340832735	2
830869	diltiazem hydrochloride 90 MG 12 HR Extended Release Oral Capsule	SY	fc02db0f-5311-4b61-896e-bfe340832735	2
830872	dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral Capsule	PSN	2ced821f-19a6-4c7e-e063-6394a90adb80	1
830872	12 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	2ced821f-19a6-4c7e-e063-6394a90adb80	1
830872	diltiazem hydrochloride 120 MG 12 HR Extended Release Oral Capsule	SY	2ced821f-19a6-4c7e-e063-6394a90adb80	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-6120-01	00378612001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6120-01)	1997-05-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride - Safecor Health LLC	Safecor Health LLC	2026-02-03	HUMAN PRESCRIPTION DRUG LABEL	2
Diltiazem Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2025-11-27	HUMAN PRESCRIPTION DRUG LABEL	13
Diltiazem Hydrochloride - Mylan Institutional Inc.	Mylan Institutional Inc.	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL	10
Diltiazem Hydrochloride - Coupler LLC	Coupler LLC	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL	1