Diltiazem Hydrochloride

Product NDC
53808-0830
11-digit product format
538080830
Labeler code
53808
Product ID
53808-0830_d7549854-f546-4224-af14-2aee940409da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA072838
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53808-0830IInactivated by FDA2026-10-05
excluded packagepackage53808-083053808-0830-1IInactivated by FDA2026-10-05

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 · 42 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 packagepackage53808-0830-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0830-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0830-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0830-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0830-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0830-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0830-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0830-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0830-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0830-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0830-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0830-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0830-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0830-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0830-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0830-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0830-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0830-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0830-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0830-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0830-19bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072838-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL1992-11-05
A072838-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL1992-11-05
A072838-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL1992-11-05
A072838-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL1992-11-05

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A072838-001DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL1992-11-0584e616aacf4f…
2026-09-14 22:38:342026-08A072838-002DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL1992-11-0584e616aacf4f…
2026-09-14 22:38:342026-08A072838-003DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL1992-11-0584e616aacf4f…
2026-09-14 22:38:342026-08A072838-004DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL1992-11-0584e616aacf4f…
2026-08-18 06:07:402026-07A072838-001DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL1992-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A072838-002DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL1992-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A072838-003DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL1992-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07A072838-004DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL1992-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072838-001DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL1992-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072838-002DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL1992-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072838-003DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL1992-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A072838-004DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL1992-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072838-001DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL1992-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072838-002DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL1992-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072838-003DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL1992-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072838-004DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL1992-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A072838-001DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL1992-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072838-002DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL1992-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072838-003DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL1992-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A072838-004DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL1992-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072838-001DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL1992-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072838-002DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL1992-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072838-003DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL1992-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072838-004DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL1992-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072838-001DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL1992-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072838-002DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL1992-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072838-003DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL1992-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072838-004DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL1992-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072838-001DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL1992-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072838-002DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL1992-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072838-003DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL1992-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072838-004DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL1992-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072838-001DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL1992-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072838-002DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL1992-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072838-003DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL1992-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072838-004DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL1992-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072838-001DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL1992-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072838-002DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL1992-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072838-003DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL1992-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072838-004DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL1992-11-055bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A072838-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A072838-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A072838-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A072838-004AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072838-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072838-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072838-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072838-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072838-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A072838-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A072838-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A072838-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072838-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A072838-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A072838-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A072838-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072838-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A072838-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A072838-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A072838-004AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072838-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A072838-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A072838-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A072838-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072838-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A072838-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A072838-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A072838-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072838-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A072838-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A072838-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A072838-004AB1ea99ee380514…

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 conceptRelationVersionEffective
61ebbccf-eedf-453b-940e-dba67b7a5fefProduct name420260107
a8d6eaa3-afcc-47e5-be12-0c9251fc8740Product name120251124
f6700316-a6ba-5e59-3413-8ede05ae58b9Product name720250625
8615f7a1-1e8f-8281-8601-d7a637926d1fProduct name420250522
3a9daa2f-bcd1-13de-a1b4-6172caa7f308Product name220240419
f7129636-cba8-86c2-8bfb-9e2e2a9c7628Product name220240314
378290be-e30f-0e68-1201-165e93c337e8Product name320231212
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0830-12020-01-31C16284748780-19d75b9d0-a861-f424-e053-dadaa90a57ceb733c439-905b-4e8f-8fc0-acde148974c4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0830-1Diltiazem Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0830DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140408_b733c439-905b-4e8f-8fc0-acde148974c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831054dilTIAZem hydrochloride 120 MG Oral TabletPSNb733c439-905b-4e8f-8fc0-acde148974c41
831054diltiazem hydrochloride 120 MG Oral TabletSCDb733c439-905b-4e8f-8fc0-acde148974c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0830-15380808300130 in 1 BLISTER PACKHistorical