Diltiazem Hydrochloride

Product NDC: 0378-0135
11-digit product format: 003780135
Labeler code: 0378
Product ID: 0378-0135_ff8dfebe-d2c4-41ca-819f-8f815a34995b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diltiazem hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA072838
Marketing category: ANDA
Marketing start: 1992-03-16
Marketing end: 0000-00-00
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 90 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0378-0135		D	Discontinued by firm	2026-10-05
excluded package	package	0378-0135	0378-0135-01	D	Discontinued by firm	2026-10-05
excluded package	package	0378-0135	0378-0135-05	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-0135-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-0135-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-0135-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-0135-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-0135-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-0135-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-0135-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-0135-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-0135-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-0135-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-0135-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-0135-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-0135-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-0135-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-0135-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-0135-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-0135-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-0135-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-0135-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-0135-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-0135-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-0135-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-0135-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-0135-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A072838-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05
A072838-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05
A072838-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05
A072838-004	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05

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 5 · 172 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	A072838-001	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072838-002	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072838-003	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072838-004	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072838-001	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072838-002	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072838-003	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072838-004	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072838-001	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072838-002	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072838-003	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072838-004	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072838-001	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072838-002	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072838-003	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072838-004	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072838-001	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072838-002	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072838-003	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072838-004	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072838-001	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072838-002	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072838-003	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072838-004	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072838-001	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072838-002	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072838-003	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072838-004	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072838-001	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072838-002	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072838-003	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072838-004	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072838-001	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072838-002	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072838-003	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072838-004	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072838-001	DILTIAZEM HYDROCHLORIDE	120MG	TABLET / ORAL	1992-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072838-002	DILTIAZEM HYDROCHLORIDE	90MG	TABLET / ORAL	1992-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072838-003	DILTIAZEM HYDROCHLORIDE	60MG	TABLET / ORAL	1992-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072838-004	DILTIAZEM HYDROCHLORIDE	30MG	TABLET / ORAL	1992-11-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A072838-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A072838-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A072838-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A072838-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072838-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072838-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072838-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072838-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072838-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A072838-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A072838-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A072838-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072838-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A072838-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A072838-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A072838-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072838-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A072838-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A072838-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A072838-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072838-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A072838-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A072838-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A072838-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072838-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A072838-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A072838-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A072838-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072838-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A072838-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A072838-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A072838-004	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0135-01	EA - Each	0378-0135	896edef1-a74f-4b07-b245-0fa9c8ff1918	1	2012-07-24
0378-0135-05	EA - Each	0378-0135	1c1d9555-99a7-4089-a65c-27aaa993a415	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 TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
DILTIAZEM	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	10
DILTIAZEM HYDROCHLORIDE	ACTIVE INGREDIENT	OLH94387TE	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
DILTIAZEM	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	8
DILTIAZEM HYDROCHLORIDE	ACTIVE INGREDIENT	OLH94387TE	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
DILTIAZEM	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	4
DILTIAZEM HYDROCHLORIDE	ACTIVE INGREDIENT	OLH94387TE	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
DILTIAZEM	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3

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
831102	dilTIAZem HCl 90 MG Oral Tablet	PSN	5443ea50-d4f6-4a75-8c8d-f6dd6978d45e	3
831054	dilTIAZem hydrochloride 120 MG Oral Tablet	PSN	5443ea50-d4f6-4a75-8c8d-f6dd6978d45e	3
833217	dilTIAZem hydrochloride 30 MG Oral Tablet	PSN	5443ea50-d4f6-4a75-8c8d-f6dd6978d45e	3
831103	dilTIAZem hydrochloride 60 MG Oral Tablet	PSN	5443ea50-d4f6-4a75-8c8d-f6dd6978d45e	3
831054	diltiazem hydrochloride 120 MG Oral Tablet	SCD	5443ea50-d4f6-4a75-8c8d-f6dd6978d45e	3
833217	diltiazem hydrochloride 30 MG Oral Tablet	SCD	5443ea50-d4f6-4a75-8c8d-f6dd6978d45e	3
831103	diltiazem hydrochloride 60 MG Oral Tablet	SCD	5443ea50-d4f6-4a75-8c8d-f6dd6978d45e	3
831102	diltiazem hydrochloride 90 MG Oral Tablet	SCD	5443ea50-d4f6-4a75-8c8d-f6dd6978d45e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0135-01	00378013501	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0135-01)	1992-03-16	0000-00-00	No	No	Current
0378-0135-05	00378013505	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0135-05)	1992-03-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride - Mylan Institutional Inc.	Mylan Institutional Inc.	2019-09-27	HUMAN PRESCRIPTION DRUG LABEL	10
Diltiazem Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2017-01-06	HUMAN PRESCRIPTION DRUG LABEL	13
DILTIAZEM HYDROCHLORIDE TABLETS, USP 30 mg, 60 mg, 90 mg and 120 mg	NCS HealthCare of KY, Inc dba Vangard Labs	2014-11-18	HUMAN PRESCRIPTION DRUG LABEL	10
Diltiazem Hydrochloride - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-12-13	HUMAN PRESCRIPTION DRUG LABEL	3