Diltiazem Hydrochloride

Product NDC
71335-1001
11-digit product format
713351001
Labeler code
71335
Product ID
71335-1001_ab8f75d5-8ef8-4d85-9430-82a1d1ecbca7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA018602
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-12-25
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
60 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-1001IInactivated by FDA2026-08-11
excluded packagepackage71335-100171335-1001-1IInactivated by FDA2026-08-11
excluded packagepackage71335-100171335-1001-2IInactivated by FDA2026-08-11
excluded packagepackage71335-100171335-1001-3IInactivated by FDA2026-08-11
excluded packagepackage71335-100171335-1001-4IInactivated by FDA2026-08-11

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 2 · 75 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 packagepackage71335-1001-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1001-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1001-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1001-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1001-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1001-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1001-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1001-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1001-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1001-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1001-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1001-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1001-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1001-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1001-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1001-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1001-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1001-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1001-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1001-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1001-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1001-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1001-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1001-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1001-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1001-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1001-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1001-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1001-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1001-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1001-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1001-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1001-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1001-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1001-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1001-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1001-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1001-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1001-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1001-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1001-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1001-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1001-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1001-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1001-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1001-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1001-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1001-4557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N018602-001CARDIZEMDILTIAZEM HYDROCHLORIDE30MGTABLET / ORALABRLD1982-11-05
N018602-002CARDIZEMDILTIAZEM HYDROCHLORIDE60MGTABLET / ORALABRLD1982-11-05
N018602-003CARDIZEMDILTIAZEM HYDROCHLORIDE90MGTABLET / ORALABRLD1986-12-08
N018602-004CARDIZEMDILTIAZEM HYDROCHLORIDE120MGTABLET / ORALABRLD, RS1986-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N018602-001AB
N018602-002AB
N018602-003AB
N018602-004AB

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
2026-02-19 14:30 UTC2026-02N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018602-001CARDIZEM30MGTABLET / ORALABRLD1982-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N018602-002CARDIZEM60MGTABLET / ORALABRLD1982-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N018602-003CARDIZEM90MGTABLET / ORALABRLD1986-12-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N018602-004CARDIZEM120MGTABLET / ORALABRLD, RS1986-12-08d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018602-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018602-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018602-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018602-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018602-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018602-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018602-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018602-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018602-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018602-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018602-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018602-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018602-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018602-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018602-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018602-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018602-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018602-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018602-004AB1d06236e962d9…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1001-1Diltiazem Hydrochloride30 in 1 BOTTLETABLET30100
71335-1001-2Diltiazem Hydrochloride90 in 1 BOTTLETABLET90100
71335-1001-3Diltiazem Hydrochloride60 in 1 BOTTLETABLET60100
71335-1001-4Diltiazem Hydrochloride100 in 1 BOTTLETABLET100100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1001DILTIAZEM HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Legacy NDC, 4 package rows20220212_13bfcfc6-deb9-439f-98ec-85a2b94b4a8a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CardizemDILTIAZEM HYDROCHLORIDEBausch Health US LLCf3e7ecef-f360-4987-a4f5-933214130ab22025-04-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 018602
application number: NDA018602
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENuCare Pharmaceuticals,Inc.636556f6-2987-984f-e053-2991aa0a201a2024-06-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 018602
application number: NDA018602
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack225a87fb-d353-4ee7-bd08-14d631ff6b162023-06-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 018602
application number: NDA018602
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEOceanside Pharmaceuticalsf6a24de7-8ffe-48af-873f-10fdcd5551d12020-06-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 018602
application number: NDA018602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN13bfcfc6-deb9-439f-98ec-85a2b94b4a8a100
831103diltiazem hydrochloride 60 MG Oral TabletSCD13bfcfc6-deb9-439f-98ec-85a2b94b4a8a100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1001-17133510010130 TABLET in 1 BOTTLE (71335-1001-1) 30 tablet2022-02-110000-00-00NoNoCurrent
71335-1001-27133510010290 TABLET in 1 BOTTLE (71335-1001-2) 90 tablet2022-02-110000-00-00NoNoCurrent
71335-1001-37133510010360 TABLET in 1 BOTTLE (71335-1001-3) 60 tablet2022-02-110000-00-00NoNoCurrent
71335-1001-471335100104100 TABLET in 1 BOTTLE (71335-1001-4) 100 tablet2022-02-110000-00-00NoNoCurrent