DILTIAZEM HYDROCHLORIDE

Product NDC
50228-499
11-digit product format
502280499
Labeler code
50228
Product ID
50228-499_2fc25445-56c7-4c39-ac18-32cc1023e7c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA216327
Marketing category
ANDA
Marketing start
2023-04-06
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
360 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A216327-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06
A216327-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06
A216327-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06
A216327-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06
A216327-005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06
A216327-006DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216327-001AB
A216327-002AB
A216327-003AB
A216327-004AB
A216327-005AB
A216327-006AB

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 4 · 150 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A216327-001DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2023-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A216327-002DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2023-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A216327-003DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2023-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A216327-004DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2023-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A216327-005DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2023-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A216327-006DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2023-04-0684e616aacf4f…
2026-08-18 06:07:402026-07A216327-001DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A216327-002DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A216327-003DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A216327-004DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A216327-005DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A216327-006DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216327-001DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216327-002DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216327-003DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216327-004DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216327-005DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216327-006DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216327-001DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2023-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216327-002DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2023-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216327-003DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2023-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216327-004DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2023-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216327-005DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2023-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216327-006DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2023-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A216327-001DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2023-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216327-002DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2023-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216327-003DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2023-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216327-004DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2023-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216327-005DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2023-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216327-006DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2023-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216327-001DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216327-002DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216327-003DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216327-004DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216327-005DILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216327-006DILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216327-001DILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216327-002DILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216327-003DILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216327-004DILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB2023-04-06b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 150 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216327-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A216327-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A216327-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A216327-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A216327-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A216327-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A216327-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216327-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216327-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216327-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216327-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216327-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216327-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216327-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216327-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216327-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216327-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216327-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216327-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216327-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216327-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216327-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216327-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216327-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216327-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216327-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216327-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216327-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216327-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216327-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216327-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216327-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216327-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216327-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216327-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216327-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216327-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216327-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216327-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216327-004AB1b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE360 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
830874Internal RxNorm lookup
830877Internal RxNorm lookup
830879Internal RxNorm lookup
830882Internal RxNorm lookup
830897Internal RxNorm lookup
830900Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ca03c9e-edc8-4c7f-89ee-f2346ea8c067Available 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-499-05DILTIAZEM HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE5002
50228-499-30DILTIAZEM HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-499DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20230417_1ca03c9e-edc8-4c7f-89ee-f2346ea8c067.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEScieGen Pharmaceuticals, Inc.1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216327
application number: ANDA216327
ndc (product): 50228-499
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECipla USA, Inc.bce61158-201d-458c-be0c-9bdd2d3a0bec2025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216327
application number: ANDA216327

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830874dilTIAZem hydrochloride 120 MG 24HR Extended Release Oral TabletPSN1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
830877dilTIAZem hydrochloride 180 MG 24HR Extended Release Oral TabletPSN1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
830879dilTIAZem hydrochloride 240 MG 24HR Extended Release Oral TabletPSN1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
830882dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral TabletPSN1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
830897dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral TabletPSN1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
830900dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral TabletPSN1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
83087424 HR diltiazem hydrochloride 120 MG Extended Release Oral TabletSCD1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
83087724 HR diltiazem hydrochloride 180 MG Extended Release Oral TabletSCD1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
83087924 HR diltiazem hydrochloride 240 MG Extended Release Oral TabletSCD1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
83088224 HR diltiazem hydrochloride 300 MG Extended Release Oral TabletSCD1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
83089724 HR diltiazem hydrochloride 360 MG Extended Release Oral TabletSCD1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
83090024 HR diltiazem hydrochloride 420 MG Extended Release Oral TabletSCD1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
830874diltiazem hydrochloride 120 MG 24 HR Extended Release Oral TabletSY1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
830877diltiazem hydrochloride 180 MG 24 HR Extended Release Oral TabletSY1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
830879diltiazem hydrochloride 240 MG 24 HR Extended Release Oral TabletSY1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
830882diltiazem hydrochloride 300 MG 24 HR Extended Release Oral TabletSY1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
830897diltiazem hydrochloride 360 MG 24 HR Extended Release Oral TabletSY1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672
830900diltiazem hydrochloride 420 MG 24 HR Extended Release Oral TabletSY1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50228-499-0550228049905500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-499-05) 2023-04-06NoNoCurrent
50228-499-305022804993030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-499-30) 2023-04-06NoNoCurrent