FDA.reportPublic FDA data

Diltiazem hydrochloride - Zydus Lifesciences Limited

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-05-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:21:20

Label at a glance#

ProductDiltiazem hydrochloride
Active ingredientDILTIAZEM HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1929-1 in bottles of 100 tablets

Diltiazem hydrochloride tablets USP, 30 mg

100 Tablets

Rx Only

30 mg 100s label
30 mg 100s label

NDC 70771-1930-1 in bottles of 100 tablets

Diltiazem hydrochloride tablets USP, 60 mg

100 Tablets

Rx Only

60 mg 100s
60 mg 100s

NDC 70771-1931-1 in bottles of 100 tablets

Diltiazem hydrochloride tablets USP, 90 mg

100 Tablets

Rx Only

90 mg 100s
90 mg 100s

NDC 70771-1932-1 in bottles of 100 tablets

Diltiazem hydrochloride tablets USP, 120 mg

100 Tablets

Rx Only

120 mg 100s
120 mg 100s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
831102dilTIAZem HCl 90 MG Oral TabletPSN1
831054dilTIAZem hydrochloride 120 MG Oral TabletPSN1
833217dilTIAZem hydrochloride 30 MG Oral TabletPSN1
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN1
831054diltiazem hydrochloride 120 MG Oral TabletSCD1
833217diltiazem hydrochloride 30 MG Oral TabletSCD1
831103diltiazem hydrochloride 60 MG Oral TabletSCD1
831102diltiazem hydrochloride 90 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DILTIAZEM Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230426

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
70771-1929-1Diltiazem hydrochloride100 in 1 BOTTLETABLET1001
70771-1929-5Diltiazem hydrochloride500 in 1 BOTTLETABLET5001
70771-1930-1Diltiazem hydrochloride100 in 1 BOTTLETABLET1001
70771-1930-5Diltiazem hydrochloride500 in 1 BOTTLETABLET5001
70771-1931-1Diltiazem hydrochloride100 in 1 BOTTLETABLET1001
70771-1931-5Diltiazem hydrochloride500 in 1 BOTTLETABLET5001
70771-1932-1Diltiazem hydrochloride100 in 1 BOTTLETABLET1001
70771-1932-5Diltiazem hydrochloride500 in 1 BOTTLETABLET5001

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-192970771-1929-1, 70771-1929-5
70771-193070771-1930-1, 70771-1930-5
70771-193170771-1931-1, 70771-1931-5
70771-193270771-1932-1, 70771-1932-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 48 matching rows.

Name, UNII, Kind table
NameUNIIKind
DILTIAZEM HYDROCHLORIDEOLH94387TEACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TALC7SEV7J4R1UIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
DILTIAZEM HYDROCHLORIDEOLH94387TEACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TALC7SEV7J4R1UIACT
DILTIAZEM HYDROCHLORIDEOLH94387TEACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TALC7SEV7J4R1UIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
DILTIAZEM HYDROCHLORIDEOLH94387TEACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limited8329d0ac-d68c-48d2-9cbc-e1a1b60192d92026-05-01Exact identifier
ndc (package): 70771-1931-1
ndc (package): 70771-1929-5
ndc (package): 70771-1930-5
ndc (package): 70771-1932-1
ndc (package): 70771-1931-5
ndc (package): 70771-1932-5
ndc (package): 70771-1929-1
ndc (package): 70771-1930-1
ndc (product): 70771-1929
ndc (product): 70771-1930
ndc (product): 70771-1932
ndc (product): 70771-1931
ndc11 (package): 70771193001
ndc11 (package): 70771192901
ndc11 (package): 70771193101
ndc11 (package): 70771193005
ndc11 (package): 70771193105
ndc11 (package): 70771193201
ndc11 (package): 70771193205
ndc11 (package): 70771192905
spl id: f63d2c9f-f49a-4b36-b25d-6fbe3ab5577f
spl set id: 8329d0ac-d68c-48d2-9cbc-e1a1b60192d9

Reported adverse events (FAERS/openFDA)#

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