FDA.reportPublic FDA data

Diltiazem hydrochloride

Product NDC
63304-719
Requested package NDC
63304-719-05
11-digit product format
633040719
Labeler code
63304
Product ID
63304-719_35b4a94c-9d26-e406-e063-6394a90aa9fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA203023
Marketing category
ANDA
Marketing start
2018-10-31
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
180 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
A203023-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08
A203023-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08
A203023-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08
A203023-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08
A203023-005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203023-005AB3

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 22:38:342026-08A203023-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-0884e616aacf4f…
2026-09-14 22:38:342026-08A203023-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-0884e616aacf4f…
2026-09-14 22:38:342026-08A203023-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-0884e616aacf4f…
2026-09-14 22:38:342026-08A203023-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-0884e616aacf4f…
2026-09-14 22:38:342026-08A203023-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-0884e616aacf4f…
2026-08-18 06:07:402026-07A203023-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203023-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203023-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203023-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A203023-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203023-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203023-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203023-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203023-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203023-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203023-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203023-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203023-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203023-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203023-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203023-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203023-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203023-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203023-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203023-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203023-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203023-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203023-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203023-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORAL2017-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203023-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203023-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203023-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203023-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203023-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203023-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203023-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203023-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203023-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203023-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203023-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32017-06-0803ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 190 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203023-005AB3184e616aacf4f…
2026-08-18 06:07:402026-07A203023-005AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203023-005AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203023-005AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203023-005AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203023-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203023-002AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203023-003AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203023-005AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203023-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203023-002AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203023-003AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203023-004AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203023-005AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203023-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203023-002AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203023-003AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203023-004AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203023-005AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203023-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203023-002AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203023-003AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203023-004AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203023-005AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203023-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203023-002AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203023-003AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203023-004AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203023-005AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203023-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203023-002AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203023-003AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203023-004AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203023-005AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203023-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A203023-002AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A203023-003AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A203023-004AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A203023-005AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203023-001AB3179d66fd596c7…

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 HYDROCHLORIDE180 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
976d9dd0-4f11-4439-b84e-0c0f0e018d8bAvailable 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
63304-719-05Diltiazem hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50010
63304-719-30Diltiazem hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010
63304-719-90Diltiazem hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-719-05EA - Each63304-71961116b34-42ca-426a-bc90-70933761e46512019-09-05
63304-719-90EA - Each63304-71933e5d711-2a5c-4589-80b5-5f5a0a3f4ed812019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-719DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]10Current NDC, Legacy NDC, 3 package rows20250523_976d9dd0-4f11-4439-b84e-0c0f0e018d8b.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 HYDROCHLORIDESun Pharmaceutical Industries, Inc.976d9dd0-4f11-4439-b84e-0c0f0e018d8b2025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203023
application number: ANDA203023
ndc (package): 63304-719-05
ndc (product): 63304-719
ndc11 (package): 63304071905
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions5460158f-7782-45f4-89b1-f84e6ba178d82023-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203023
application number: ANDA203023

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSN976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCD976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSY976d9dd0-4f11-4439-b84e-0c0f0e018d8b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-719-0563304071905500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-719-05) 2018-10-310000-00-00NoNoCurrent