Diltiazem Hydrochloride

Product NDC
50228-482
11-digit product format
502280482
Labeler code
50228
Product ID
50228-482_31a9f85e-b3f0-4b39-a133-8d4324df2aff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc
Application
ANDA216521
Marketing category
ANDA
Marketing start
2022-09-26
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
60 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

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
A216521-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2022-09-23
A216521-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2022-09-23
A216521-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2022-09-23
A216521-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2022-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216521-001AB
A216521-002AB
A216521-003AB
A216521-004AB

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 3 · 112 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A216521-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2022-09-2384e616aacf4f…
2026-09-14 22:38:342026-08A216521-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2022-09-2384e616aacf4f…
2026-09-14 22:38:342026-08A216521-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2022-09-2384e616aacf4f…
2026-09-14 22:38:342026-08A216521-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2022-09-2384e616aacf4f…
2026-08-18 06:07:402026-07A216521-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2022-09-23caaa826d4ba7…
2026-08-18 06:07:402026-07A216521-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2022-09-23caaa826d4ba7…
2026-08-18 06:07:402026-07A216521-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2022-09-23caaa826d4ba7…
2026-08-18 06:07:402026-07A216521-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2022-09-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216521-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2022-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216521-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2022-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216521-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2022-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216521-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2022-09-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216521-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2022-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216521-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2022-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216521-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2022-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216521-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2022-09-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A216521-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2022-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216521-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2022-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216521-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2022-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216521-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2022-09-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216521-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2022-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216521-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2022-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216521-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2022-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216521-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2022-09-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216521-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2022-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216521-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2022-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216521-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2022-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216521-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2022-09-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216521-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2022-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216521-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2022-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216521-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2022-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216521-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2022-09-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216521-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2022-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216521-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2022-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216521-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2022-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216521-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2022-09-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216521-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2022-09-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216521-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2022-09-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216521-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2022-09-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216521-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2022-09-235bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216521-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A216521-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A216521-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A216521-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A216521-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216521-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216521-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216521-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216521-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216521-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216521-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216521-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216521-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216521-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216521-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216521-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216521-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216521-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216521-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216521-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216521-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216521-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216521-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216521-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216521-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216521-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216521-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216521-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216521-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216521-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216521-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216521-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216521-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216521-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216521-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216521-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216521-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216521-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216521-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216521-004AB15bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
Diltiazem Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE60 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
831054Internal RxNorm lookup
831102Internal RxNorm lookup
831103Internal RxNorm lookup
833217Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
196fc367-330e-4d15-b1d6-084ad3f97ae7Available 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
50228-482-01Diltiazem Hydrochloride100 in 1 BOTTLETABLET1003
50228-482-05Diltiazem Hydrochloride500 in 1 BOTTLETABLET5003
50228-482-10Diltiazem Hydrochloride1000 in 1 BOTTLETABLET10003
50228-482-30Diltiazem Hydrochloride30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-482-01EA - Each50228-48292d72dd1-4c3e-4067-866b-3309d30349e112023-02-06
50228-482-05EA - Each50228-482dc4a3230-74cf-4b11-b8c0-eafc2b40821b12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-482DILTIAZEM HYDROCHLORIDE TABLET DILTIAZEM HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS, INC]2Current NDC, Legacy NDC, 4 package rows20230124_196fc367-330e-4d15-b1d6-084ad3f97ae7.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack50df9f09-aa2f-495d-a25c-7c5c0fdffcf02026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216521
application number: ANDA216521
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack76e04232-b3da-48e8-a944-5f4f97a508df2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216521
application number: ANDA216521
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENorthwind Health Company, LLC106b33e3-b199-e555-e063-6294a90a5af52026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216521
application number: ANDA216521
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENorthwind Health Company, LLC09a5d332-347b-e73d-e063-6294a90a67ed2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216521
application number: ANDA216521
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEScieGen Pharmaceuticals, Inc196fc367-330e-4d15-b1d6-084ad3f97ae72025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216521
application number: ANDA216521
ndc (product): 50228-482
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECoupler LLC3418eb02-117e-a71a-e063-6394a90a826e2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216521
application number: ANDA216521
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECoupler LLC2cd92b83-075e-b069-e063-6294a90a9fff2025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216521
application number: ANDA216521
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions88b150a6-4c8d-49c8-88df-f3606c3354722024-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216521
application number: ANDA216521

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831102dilTIAZem HCl 90 MG Oral TabletPSN196fc367-330e-4d15-b1d6-084ad3f97ae73
831054dilTIAZem hydrochloride 120 MG Oral TabletPSN196fc367-330e-4d15-b1d6-084ad3f97ae73
833217dilTIAZem hydrochloride 30 MG Oral TabletPSN196fc367-330e-4d15-b1d6-084ad3f97ae73
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN196fc367-330e-4d15-b1d6-084ad3f97ae73
831054diltiazem hydrochloride 120 MG Oral TabletSCD196fc367-330e-4d15-b1d6-084ad3f97ae73
833217diltiazem hydrochloride 30 MG Oral TabletSCD196fc367-330e-4d15-b1d6-084ad3f97ae73
831103diltiazem hydrochloride 60 MG Oral TabletSCD196fc367-330e-4d15-b1d6-084ad3f97ae73
831102diltiazem hydrochloride 90 MG Oral TabletSCD196fc367-330e-4d15-b1d6-084ad3f97ae73
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN09a5d332-347b-e73d-e063-6294a90a67ed2
831103diltiazem hydrochloride 60 MG Oral TabletSCD09a5d332-347b-e73d-e063-6294a90a67ed2
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN88b150a6-4c8d-49c8-88df-f3606c3354721
831103diltiazem hydrochloride 60 MG Oral TabletSCD88b150a6-4c8d-49c8-88df-f3606c3354721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-482-0150228048201100 TABLET in 1 BOTTLE (50228-482-01) 100 tablet2022-09-26NoNoCurrent
50228-482-0550228048205500 TABLET in 1 BOTTLE (50228-482-05) 500 tablet2022-09-26NoNoCurrent
50228-482-10502280482101000 TABLET in 1 BOTTLE (50228-482-10) 1000 tablet2022-09-260000-00-00NoNoCurrent
50228-482-305022804823030 TABLET in 1 BOTTLE (50228-482-30) 30 tablet2022-09-260000-00-00NoNoCurrent