FDA.reportPublic FDA data

Diltiazem hydrochloride

Product NDC
72578-201
11-digit product format
725780201
Labeler code
72578
Product ID
72578-201_d8065fba-91ec-4dc5-86a5-869a70100565
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA219253
Marketing category
ANDA
Marketing start
2026-05-25
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
90 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219253-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2025-08-08
A219253-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2025-08-08
A219253-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2025-08-08
A219253-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2025-08-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219253-001AB
A219253-002AB
A219253-003AB
A219253-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219253-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2025-08-0884e616aacf4f…
2026-09-14 22:38:342026-08A219253-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2025-08-0884e616aacf4f…
2026-09-14 22:38:342026-08A219253-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2025-08-0884e616aacf4f…
2026-09-14 22:38:342026-08A219253-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2025-08-0884e616aacf4f…
2026-08-18 06:07:402026-07A219253-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2025-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07A219253-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2025-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07A219253-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2025-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07A219253-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2025-08-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219253-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORAL2025-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219253-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORAL2025-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219253-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORAL2025-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219253-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORAL2025-08-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219253-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2025-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219253-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2025-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219253-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2025-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219253-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2025-08-0831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219253-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB2025-08-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219253-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB2025-08-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219253-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB2025-08-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219253-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB2025-08-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219253-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A219253-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A219253-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A219253-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A219253-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219253-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219253-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219253-004AB1caaa826d4ba7…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219253-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219253-004AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219253-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219253-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219253-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219253-004AB1a50c72e98297…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE90 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
43cffe12-304a-4e15-9512-94f812188f1aAvailable 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
72578-201-01Diltiazem hydrochloride100 in 1 BOTTLETABLET1001
72578-201-05Diltiazem hydrochloride500 in 1 BOTTLETABLET5001

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 HYDROCHLORIDEZydus Lifesciences Limited8329d0ac-d68c-48d2-9cbc-e1a1b60192d92026-05-01Exact identifier
application applno (ANDA): 219253
application number: ANDA219253
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEViona Pharmaceuticals Inc43cffe12-304a-4e15-9512-94f812188f1a2025-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219253
application number: ANDA219253
ndc (product): 72578-201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831102dilTIAZem HCl 90 MG Oral TabletPSN43cffe12-304a-4e15-9512-94f812188f1a1
831054dilTIAZem hydrochloride 120 MG Oral TabletPSN43cffe12-304a-4e15-9512-94f812188f1a1
833217dilTIAZem hydrochloride 30 MG Oral TabletPSN43cffe12-304a-4e15-9512-94f812188f1a1
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN43cffe12-304a-4e15-9512-94f812188f1a1
831054diltiazem hydrochloride 120 MG Oral TabletSCD43cffe12-304a-4e15-9512-94f812188f1a1
833217diltiazem hydrochloride 30 MG Oral TabletSCD43cffe12-304a-4e15-9512-94f812188f1a1
831103diltiazem hydrochloride 60 MG Oral TabletSCD43cffe12-304a-4e15-9512-94f812188f1a1
831102diltiazem hydrochloride 90 MG Oral TabletSCD43cffe12-304a-4e15-9512-94f812188f1a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72578-201-0172578020101100 TABLET in 1 BOTTLE (72578-201-01) 100 tablet2026-05-25NoNoCurrent
72578-201-0572578020105500 TABLET in 1 BOTTLE (72578-201-05) 500 tablet2026-05-25NoNoCurrent