Diltiazem Hydrochloride

Product NDC: 47335-672
11-digit product format: 473350672
Labeler code: 47335
Product ID: 47335-672_ecddf1f1-b8e7-4a08-8f00-6cc484092a5f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA090421
Marketing category: ANDA
Marketing start: 2010-11-15
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 43.

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	Approval date
A090421-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15
A090421-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15
A090421-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15
A090421-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15
A090421-005	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15

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 · 215 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	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090421-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090421-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090421-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090421-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090421-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	2010-11-15	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 165 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090421-001	AB4	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090421-002	AB4	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090421-003	AB4	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090421-004	AB4	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090421-005	AB4	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090421-001	AB4	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090421-002	AB4	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090421-003	AB4	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090421-004	AB4	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090421-005	AB4	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090421-001	AB4	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090421-002	AB4	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090421-003	AB4	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090421-004	AB4	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090421-005	AB4	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090421-001	AB4	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090421-002	AB4	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090421-003	AB4	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090421-004	AB4	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090421-005	AB4	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090421-001	AB4	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090421-002	AB4	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090421-003	AB4	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090421-004	AB4	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090421-005	AB4	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090421-001	AB4	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090421-002	AB4	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090421-003	AB4	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090421-004	AB4	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090421-005	AB4	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090421-001	AB4	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090421-002	AB4	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090421-003	AB4	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090421-004	AB4	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090421-005	AB4	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090421-001	AB4	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090421-002	AB4	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090421-003	AB4	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090421-004	AB4	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090421-005	AB4	1	`5c6f7cd8ea54…`

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	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
eebf29fe-ce22-4482-b850-5854550bf2c4	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
47335-672-13	Diltiazem Hydrochloride	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500	11
47335-672-18	Diltiazem Hydrochloride	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000	11
47335-672-19	Diltiazem Hydrochloride	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	11
47335-672-81	Diltiazem Hydrochloride	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	11
47335-672-83	Diltiazem Hydrochloride	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-672-13	EA - Each	47335-672	873b4dc5-2fb9-4976-9f5b-0436c4872ead	1	2012-07-24
47335-672-81	EA - Each	47335-672	8bb55b9b-3d1c-40fd-8c92-371901b3deb3	1	2012-07-24
47335-672-83	EA - Each	47335-672	a1622762-e6b9-4473-b491-e38f75b9f7b6	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 [SUN PHARMA GLOBAL FZE]	6
DILTIAZEM	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	6
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	6
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	6
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	6
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	6
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-672	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	11	Current NDC, Legacy NDC, 5 package rows	20230812_eebf29fe-ce22-4482-b850-5854550bf2c4.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	Sun Pharmaceutical Industries, Inc.	eebf29fe-ce22-4482-b850-5854550bf2c4	2023-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090421 application number: ANDA090421 ndc (product): 47335-672

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	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830845	dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule	PSN	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830837	dilTIAZem HCl 240 MG 24HR Extended Release Oral Capsule	PSN	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830801	dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral Capsule	PSN	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830795	dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral Capsule	PSN	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830861	24 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830845	24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule	SCD	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830837	24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule	SCD	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830801	24 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule	SCD	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830795	24 HR diltiazem hydrochloride 360 MG Extended Release Oral Capsule	SCD	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830861	diltiazem HCl 120 MG 24 HR Extended Release Oral Capsule	SY	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830845	diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule	SY	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830837	diltiazem HCl 240 MG 24 HR Extended Release Oral Capsule	SY	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830801	diltiazem hydrochloride 300 MG 24 HR Extended Release Oral Capsule	SY	eebf29fe-ce22-4482-b850-5854550bf2c4	11
830795	diltiazem hydrochloride 360 MG 24 HR Extended Release Oral Capsule	SY	eebf29fe-ce22-4482-b850-5854550bf2c4	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-672-13	47335067213	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-672-13)	2010-11-15	0000-00-00	No	No	Current
47335-672-18	47335067218	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-672-18)	2010-11-15	0000-00-00	No	No	Current
47335-672-19	47335067219	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-672-19)	2010-11-15	0000-00-00	No	No	Current
47335-672-81	47335067281	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-672-81)	2010-11-15	0000-00-00	No	No	Current
47335-672-83	47335067283	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-672-83)	2010-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride Extended-release Capsules, USP	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2023-08-04	Human Prescription Drug Label	11