Diltiazem Hydrochloride

Product NDC: 0904-7218
11-digit product format: 009047218
Labeler code: 0904
Product ID: 0904-7218_ef66f466-b51f-4f29-b7a0-f8acc80d3562
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA205231
Marketing category: ANDA
Marketing start: 2022-08-09
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 180 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205231-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30
A205231-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30
A205231-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30
A205231-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30
A205231-005	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205231-001	AB3
A205231-002	AB3
A205231-003	AB3
A205231-004	AB3
A205231-005	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	A205231-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205231-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205231-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205231-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205231-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205231-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205231-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205231-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205231-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205231-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205231-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205231-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205231-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205231-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205231-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205231-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205231-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205231-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205231-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205231-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205231-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205231-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205231-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205231-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205231-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205231-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205231-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205231-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205231-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205231-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205231-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205231-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205231-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205231-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205231-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205231-001	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205231-002	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205231-003	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205231-004	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205231-005	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	2018-08-30	`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	A205231-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205231-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205231-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205231-004	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205231-005	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205231-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205231-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205231-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205231-004	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205231-005	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205231-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205231-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205231-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205231-004	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205231-005	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205231-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205231-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205231-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205231-004	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205231-005	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205231-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205231-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205231-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205231-004	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205231-005	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205231-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205231-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205231-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205231-004	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205231-005	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205231-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205231-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205231-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205231-004	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205231-005	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205231-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205231-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205231-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205231-004	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205231-005	AB3	1	`5bbf6a4d5a75…`

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	180 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
e7476adc-a940-4e76-a1dd-c418de493bc0	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
0904-7218-61	Diltiazem Hydrochloride	1 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	1		5
0904-7218-61	Diltiazem Hydrochloride	100 in 1 CARTON	CAPSULE, EXTENDED RELEASE	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7218-61	EA - Each	0904-7218	d98b2f90-0bf8-4459-b676-2f94485b78c5	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7218	DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	2	Current NDC, Legacy NDC, 2 package rows	20240724_e7476adc-a940-4e76-a1dd-c418de493bc0.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Major Pharmaceuticals	e7476adc-a940-4e76-a1dd-c418de493bc0	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205231 application number: ANDA205231 ndc (product): 0904-7218
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	465dbab3-f201-4441-8f55-92a843b5134f	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205231 application number: ANDA205231
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Golden State Medical Supply, Inc.	c9f17187-e958-106b-e053-2a95a90a54d8	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205231 application number: ANDA205231
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Cardinal Health 107, LLC	bdb9e7cf-bfbb-48b4-a8be-9038820d8279	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205231 application number: ANDA205231
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	bb32d681-9a83-431e-9984-a5cee2c94852	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205231 application number: ANDA205231
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	839af3af-4040-4cf4-8d4a-881a053514cc	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205231 application number: ANDA205231
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	22e653e5-4122-4d7d-b9ad-0bdc1390fb40	2025-10-20	Adverse reactions	Exact identifier application applno (ANDA): 205231 application number: ANDA205231
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	c8809dc9-b99b-4d30-a7da-0bc21aa90f9c	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205231 application number: ANDA205231
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE	A-S Medication Solutions	f317de31-495c-4268-8171-89534bf1dd36	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205231 application number: ANDA205231

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	bdb9e7cf-bfbb-48b4-a8be-9038820d8279	6
830845	dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule	PSN	bdb9e7cf-bfbb-48b4-a8be-9038820d8279	6
830837	dilTIAZem HCl 240 MG 24HR Extended Release Oral Capsule	PSN	bdb9e7cf-bfbb-48b4-a8be-9038820d8279	6
830861	24 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	bdb9e7cf-bfbb-48b4-a8be-9038820d8279	6
830845	24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule	SCD	bdb9e7cf-bfbb-48b4-a8be-9038820d8279	6
830837	24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule	SCD	bdb9e7cf-bfbb-48b4-a8be-9038820d8279	6
830861	diltiazem HCl 120 MG 24 HR Extended Release Oral Capsule	SY	bdb9e7cf-bfbb-48b4-a8be-9038820d8279	6
830845	diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule	SY	bdb9e7cf-bfbb-48b4-a8be-9038820d8279	6
830837	diltiazem HCl 240 MG 24 HR Extended Release Oral Capsule	SY	bdb9e7cf-bfbb-48b4-a8be-9038820d8279	6
830861	dilTIAZem HCl 120 MG 24HR Extended Release Oral Capsule	PSN	e7476adc-a940-4e76-a1dd-c418de493bc0	5
830845	dilTIAZem HCl 180 MG 24HR Extended Release Oral Capsule	PSN	e7476adc-a940-4e76-a1dd-c418de493bc0	5
830837	dilTIAZem HCl 240 MG 24HR Extended Release Oral Capsule	PSN	e7476adc-a940-4e76-a1dd-c418de493bc0	5
830801	dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral Capsule	PSN	e7476adc-a940-4e76-a1dd-c418de493bc0	5
830861	24 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	e7476adc-a940-4e76-a1dd-c418de493bc0	5
830845	24 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule	SCD	e7476adc-a940-4e76-a1dd-c418de493bc0	5
830837	24 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule	SCD	e7476adc-a940-4e76-a1dd-c418de493bc0	5
830801	24 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule	SCD	e7476adc-a940-4e76-a1dd-c418de493bc0	5
830861	diltiazem HCl 120 MG 24 HR Extended Release Oral Capsule	SY	e7476adc-a940-4e76-a1dd-c418de493bc0	5
830845	diltiazem HCl 180 MG 24 HR Extended Release Oral Capsule	SY	e7476adc-a940-4e76-a1dd-c418de493bc0	5
830837	diltiazem HCl 240 MG 24 HR Extended Release Oral Capsule	SY	e7476adc-a940-4e76-a1dd-c418de493bc0	5
830801	diltiazem hydrochloride 300 MG 24 HR Extended Release Oral Capsule	SY	e7476adc-a940-4e76-a1dd-c418de493bc0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7218-61	00904721861	100 BLISTER PACK in 1 CARTON (0904-7218-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK	100 blister pack	2022-08-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem ER Capsules Rx only	Major Pharmaceuticals	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	6
Diltiazem ER Capsules Rx only	Cardinal Health 107, LLC	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	6