Diltiazem Hydrochloride

Product NDC
0378-5280
11-digit product format
003785280
Labeler code
0378
Product ID
0378-5280_da44b851-4185-4937-b1a6-3b1b2bc82f3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075124
Marketing category
ANDA
Marketing start
1998-03-24
Marketing end
2019-10-31
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-5280DDiscontinued by firm2026-10-12
excluded packagepackage0378-52800378-5280-01DDiscontinued by firm2026-10-12
excluded packagepackage0378-52800378-5280-05DDiscontinued by firm2026-10-12

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-5280-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0378-5280-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-5280-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-5280-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-5280-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-5280-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-5280-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-5280-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-5280-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-5280-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-5280-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-5280-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-5280-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-5280-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-5280-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-5280-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-5280-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-5280-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-5280-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-5280-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-5280-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-5280-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-5280-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-5280-01557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075124-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18
A075124-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18
A075124-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1884e616aacf4f…
2026-09-14 22:38:342026-08A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1884e616aacf4f…
2026-09-14 22:38:342026-08A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1884e616aacf4f…
2026-08-18 06:07:402026-07A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075124-002DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075124-003DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075124-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL1998-03-18301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A075124-001AB21b00525d2431f…
2019-09-15 20:21 UTC2019-09A075124-003AB21b00525d2431f…
2019-07-19 19:46 UTC2019-07A075124-001AB21ea99ee380514…
2019-07-19 19:46 UTC2019-07A075124-002AB21ea99ee380514…
2019-07-19 19:46 UTC2019-07A075124-003AB21ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5280-01EA - Each0378-52806c883894-1ff1-4399-a00b-c2988e8f627d12012-07-24
0378-5280-05EA - Each0378-52802645725e-6c35-423a-a2bd-2c4bc3c667e712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
DILTIAZEMACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
AMMONIAINACTIVE INGREDIENT5138Q19F1XDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
GELATININACTIVE INGREDIENT2G86QN327LDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
SHELLACINACTIVE INGREDIENT46N107B71ODILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7