DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE

Product NDC
72189-248
Requested package NDC
72189-248-90
11-digit product format
721890248
Labeler code
72189
Product ID
72189-248_2c2871ee-eb23-78d5-e063-6294a90a2de9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
direct rx
Application
NDA020401
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-07-23
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
240 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-24872189-248-90UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-24872189-248-90UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020401-001TIAZACDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11
N020401-002TIAZACDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11
N020401-003TIAZACDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11
N020401-004TIAZACDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11
N020401-005TIAZACDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11
N020401-006TIAZACDILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
N020401-001AB4
N020401-002AB4
N020401-003AB4
N020401-004AB4
N020401-005AB4
N020401-006AB4

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-112680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020401-001AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-002AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-003AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-004AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-005AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-006AB41011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-001AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-002AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-003AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-004AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-005AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-006AB4131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020401-001AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-002AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-003AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-004AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-005AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-006AB416a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-001AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-002AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-003AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-004AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-005AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-006AB41fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-001AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-002AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-003AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-004AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-005AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-006AB41b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-001AB4103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-002AB4103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-003AB4103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-004AB4103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-005AB4103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-006AB4103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-001AB412680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-002AB412680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-003AB412680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-004AB412680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OLH94387TEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
830837Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c7cf9276-4b4c-10b2-e053-2995a90a3738Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-248-90DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-248-90EA - Each72189-24862a28cd2-eb0b-4ada-95f5-fae5fd87cab812021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-248DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE CAPSULE, EXTENDED RELEASE [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20250121_c7cf9276-4b4c-10b2-e053-2995a90a3738.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIAZAC EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBausch Health US, LLCc567fe7e-887e-4291-a0d1-2dd3f25cbf252025-11-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 020401
application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack58eeb8bc-91d0-4cf8-a0d7-be3548d921962025-11-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 020401
application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEOceanside Pharmaceuticals862d65cb-a732-4786-b569-bad2eaafddfd2025-10-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 020401
application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc7c6a74e-5f73-4265-a0e0-8fd2cd26909e2025-01-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020401
application number: NDA020401
DILTIAZEM HYDROCHLORIDE EXTENDED RELEASEDILTIAZEM HYDROCHLORIDE EXTENDED RELEASEdirect rxc7cf9276-4b4c-10b2-e053-2995a90a37382025-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 020401
application number: NDA020401
ndc (package): 72189-248-90
ndc (product): 72189-248
ndc11 (package): 72189024890

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNc7cf9276-4b4c-10b2-e053-2995a90a37382
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDc7cf9276-4b4c-10b2-e053-2995a90a37382
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYc7cf9276-4b4c-10b2-e053-2995a90a37382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-248-907218902489090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-248-90) 2021-07-230000-00-00NoNoCurrent