Diltiazem Hydrochloride

Product NDC: 0228-2918
11-digit product format: 002282918
Labeler code: 0228
Product ID: 0228-2918_3bfa9909-89ed-47d3-8e01-0c688a59a093
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA202463
Marketing category: ANDA
Marketing start: 2013-11-25
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202463-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3		2012-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202463-001	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 2 · 41 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	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202463-001	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2012-12-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A202463-001	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202463-001	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202463-001	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202463-001	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202463-001	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202463-001	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202463-001	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202463-001	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202463-001	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202463-001	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202463-001	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202463-001	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202463-001	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202463-001	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202463-001	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202463-001	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202463-001	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202463-001	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202463-001	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202463-001	AB3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202463-001	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202463-001	AB3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202463-001	AB3	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202463-001	AB3	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202463-001	AB3	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202463-001	AB3	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202463-001	AB3	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202463-001	AB3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202463-001	AB3	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202463-001	AB3	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202463-001	AB3	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202463-001	AB3	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202463-001	AB3	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202463-001	AB3	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202463-001	AB3	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202463-001	AB3	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202463-001	AB3	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202463-001	AB3	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202463-001	AB3	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202463-001	AB3	1	`cb3db0bc1861…`

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	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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
830795	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
178eec1f-1d4d-4a38-b66a-d3ba3de06c3d	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
0228-2918-09	Diltiazem Hydrochloride	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0228-2918-09	EA - Each	0228-2918	470b2c33-186c-4899-81db-3064612e637c	1	2014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DILTIAZEM HYDROCHLORIDE	ACTIVE INGREDIENT	OLH94387TE	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
DILTIAZEM	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	INACTIVE INGREDIENT	5KY68S2577	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0228-2918	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20220204_178eec1f-1d4d-4a38-b66a-d3ba3de06c3d.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	Actavis Pharma, Inc.	178eec1f-1d4d-4a38-b66a-d3ba3de06c3d	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202463 application number: ANDA202463 ndc (product): 0228-2918

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
830795	dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral Capsule	PSN	178eec1f-1d4d-4a38-b66a-d3ba3de06c3d	9
830795	24 HR diltiazem hydrochloride 360 MG Extended Release Oral Capsule	SCD	178eec1f-1d4d-4a38-b66a-d3ba3de06c3d	9
830795	diltiazem hydrochloride 360 MG 24 HR Extended Release Oral Capsule	SY	178eec1f-1d4d-4a38-b66a-d3ba3de06c3d	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0228-2918-09	00228291809	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2918-09)	2013-11-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride Extended-Release Capsules, USP	Actavis Pharma, Inc.	2025-05-31	HUMAN PRESCRIPTION DRUG LABEL	8