Diltiazem Hydrochloride

Product NDC
21695-410
11-digit product format
216950410
Labeler code
21695
Product ID
21695-410_dfd30506-59e5-4578-879e-fbd6fdd90515
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA072838
Marketing category
ANDA
Marketing start
1992-11-05
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
E
Listing certified through
2017-12-31
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 productproduct21695-410IInactivated by FDA2026-10-05
excluded packagepackage21695-41021695-410-30IInactivated 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 · 44 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 packagepackage21695-410-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-410-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-410-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-410-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-410-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-410-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-410-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-410-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-410-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-410-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-410-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-410-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-410-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-410-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-410-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-410-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-410-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-410-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-410-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-410-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-410-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-410-30110d247fa046…a55b01930146…

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
21695-410-302019-09-24C16284748780-1934fe258-4bfc-48b1-e053-8cdaa90a720aDILTIAZEM HYDROCHLORIDE TABLETS, USP 60 mg and 120 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-410-30Diltiazem Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-410-30EA - Each21695-410813e6a11-2649-457b-987d-c994fbb06fc512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-410DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110103_dfd30506-59e5-4578-879e-fbd6fdd90515.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831054dilTIAZem hydrochloride 120 MG Oral TabletPSNdfd30506-59e5-4578-879e-fbd6fdd905151
831103dilTIAZem hydrochloride 60 MG Oral TabletPSNdfd30506-59e5-4578-879e-fbd6fdd905151
831054diltiazem hydrochloride 120 MG Oral TabletSCDdfd30506-59e5-4578-879e-fbd6fdd905151
831103diltiazem hydrochloride 60 MG Oral TabletSCDdfd30506-59e5-4578-879e-fbd6fdd905151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-410-302169504103030 in 1 BOTTLE, PLASTICHistorical