FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
42799-131
11-digit product format
427990131
Labeler code
42799
Product ID
42799-131_5b90e43a-b550-4a28-b9f8-5f1b4663201a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA211596
Marketing category
ANDA
Marketing start
2018-10-29
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
2023-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42799-131DDiscontinued by firm2026-10-15
excluded packagepackage42799-13142799-131-01DDiscontinued by firm2026-10-15
excluded packagepackage42799-13142799-131-02DDiscontinued by firm2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A211596-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL2019-11-18
A211596-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL2019-11-18
A211596-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL2019-11-18
A211596-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL2019-11-18

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A211596-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL2019-11-18c2088c7a36db…
2026-10-15 13:18:302026-09A211596-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL2019-11-18c2088c7a36db…
2026-10-15 13:18:302026-09A211596-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL2019-11-18c2088c7a36db…
2026-10-15 13:18:302026-09A211596-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL2019-11-18c2088c7a36db…
2026-09-14 22:38:342026-08A211596-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL2019-11-1884e616aacf4f…
2026-09-14 22:38:342026-08A211596-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL2019-11-1884e616aacf4f…
2026-09-14 22:38:342026-08A211596-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL2019-11-1884e616aacf4f…
2026-09-14 22:38:342026-08A211596-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL2019-11-1884e616aacf4f…
2026-08-18 06:07:402026-07A211596-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL2019-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07A211596-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL2019-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07A211596-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL2019-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07A211596-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL2019-11-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211596-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL2019-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211596-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL2019-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211596-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL2019-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211596-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL2019-11-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211596-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL2019-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211596-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL2019-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211596-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL2019-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211596-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL2019-11-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211596-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL2019-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211596-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL2019-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211596-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL2019-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211596-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL2019-11-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211596-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL2019-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211596-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL2019-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211596-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL2019-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211596-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL2019-11-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211596-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL2019-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211596-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL2019-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211596-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL2019-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211596-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL2019-11-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211596-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL2019-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211596-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL2019-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211596-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL2019-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211596-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL2019-11-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211596-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL2019-11-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211596-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL2019-11-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211596-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL2019-11-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211596-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL2019-11-182680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211596-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211596-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211596-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211596-004AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211596-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211596-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211596-003AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211596-004AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211596-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A211596-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A211596-003AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A211596-004AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211596-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A211596-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A211596-003AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A211596-004AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211596-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211596-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211596-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211596-004AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211596-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A211596-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A211596-003AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A211596-004AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211596-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A211596-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A211596-003AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A211596-004AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211596-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211596-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211596-003AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211596-004AB1cb3db0bc1861…

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
42799-131-01EA - Each42799-1315bc9d623-61e8-4991-9447-3291d947744f12020-04-20
42799-131-02EA - Each42799-1319834c9b3-74c4-47c8-9cf6-6cedcc9cb57412020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-131DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [EDENBRIDGE PHARMACEUTICALS LLC.]6Legacy NDC20220115_14a67570-6820-46ee-920c-b6d3663609d9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42799-131-0142799013101100 TABLET, FILM COATED in 1 BOTTLE (42799-131-01) 2018-10-290000-00-00NoNoCurrent
42799-131-0242799013102500 TABLET, FILM COATED in 1 BOTTLE (42799-131-02) 2018-10-290000-00-00NoNoCurrent