diltiazem hydrochloride

Product NDC
70771-1032
11-digit product format
707711032
Labeler code
70771
Product ID
70771-1032_99889af0-9650-495d-9834-3cb0e77cda5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA206534
Marketing category
ANDA
Marketing start
2017-09-28
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

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206534-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08
A206534-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08
A206534-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08
A206534-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08
A206534-005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A206534-001AB3
A206534-002AB3
A206534-003AB3
A206534-004AB3
A206534-005AB3

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206534-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0884e616aacf4f…
2026-09-14 22:38:342026-08A206534-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0884e616aacf4f…
2026-09-14 22:38:342026-08A206534-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0884e616aacf4f…
2026-09-14 22:38:342026-08A206534-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0884e616aacf4f…
2026-09-14 22:38:342026-08A206534-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0884e616aacf4f…
2026-08-18 06:07:402026-07A206534-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206534-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206534-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206534-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206534-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206534-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206534-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206534-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206534-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206534-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206534-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206534-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206534-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206534-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206534-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206534-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206534-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206534-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206534-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206534-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206534-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206534-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206534-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206534-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206534-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206534-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206534-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206534-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206534-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206534-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206534-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206534-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206534-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206534-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206534-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-08-0803ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206534-001AB3184e616aacf4f…
2026-09-14 22:38:342026-08A206534-002AB3184e616aacf4f…
2026-09-14 22:38:342026-08A206534-003AB3184e616aacf4f…
2026-09-14 22:38:342026-08A206534-004AB3184e616aacf4f…
2026-09-14 22:38:342026-08A206534-005AB3184e616aacf4f…
2026-08-18 06:07:402026-07A206534-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A206534-002AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A206534-003AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A206534-004AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A206534-005AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206534-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206534-002AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206534-003AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206534-004AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206534-005AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206534-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206534-002AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206534-003AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206534-004AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206534-005AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206534-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206534-002AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206534-003AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206534-004AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206534-005AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206534-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206534-002AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206534-003AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206534-004AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206534-005AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206534-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206534-002AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206534-003AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206534-004AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206534-005AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206534-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206534-002AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206534-003AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206534-004AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206534-005AB3103ed91905a0d…

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 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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
830795Internal RxNorm lookup
830801Internal RxNorm lookup
830837Internal RxNorm lookup
830845Internal RxNorm lookup
830861Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe790439-85d4-4cd8-a385-149ea3442a38Available 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
70771-1032-1diltiazem hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1006
70771-1032-3diltiazem hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE306
70771-1032-4diltiazem hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE106
70771-1032-4diltiazem hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE106
70771-1032-5diltiazem hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5006
70771-1032-9diltiazem hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1032DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 6 package rows20250502_fe790439-85d4-4cd8-a385-149ea3442a38.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc044f774-783f-4920-a8a1-6d4b1b3820c12025-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206534
application number: ANDA206534
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.1e2f2025-0350-40c4-ab42-3b57f3d105a62025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206534
application number: ANDA206534
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limitedfe790439-85d4-4cd8-a385-149ea3442a382025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206534
application number: ANDA206534
ndc (product): 70771-1032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSNfe790439-85d4-4cd8-a385-149ea3442a386
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNfe790439-85d4-4cd8-a385-149ea3442a386
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNfe790439-85d4-4cd8-a385-149ea3442a386
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSNfe790439-85d4-4cd8-a385-149ea3442a386
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSNfe790439-85d4-4cd8-a385-149ea3442a386
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDfe790439-85d4-4cd8-a385-149ea3442a386
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDfe790439-85d4-4cd8-a385-149ea3442a386
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDfe790439-85d4-4cd8-a385-149ea3442a386
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCDfe790439-85d4-4cd8-a385-149ea3442a386
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCDfe790439-85d4-4cd8-a385-149ea3442a386
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSYfe790439-85d4-4cd8-a385-149ea3442a386
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYfe790439-85d4-4cd8-a385-149ea3442a386
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYfe790439-85d4-4cd8-a385-149ea3442a386
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYfe790439-85d4-4cd8-a385-149ea3442a386
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSYfe790439-85d4-4cd8-a385-149ea3442a386

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1032-170771103201100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1032-1) 2017-09-280000-00-00NoNoCurrent
70771-1032-37077110320330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1032-3) 2017-09-280000-00-00NoNoCurrent
70771-1032-47077110320410 BLISTER PACK in 1 CARTON (70771-1032-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2017-09-280000-00-00NoNoCurrent
70771-1032-570771103205500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1032-5) 2018-10-020000-00-00NoNoCurrent
70771-1032-97077110320990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1032-9) 2017-09-280000-00-00NoNoCurrent