Diltiazem Hydrochloride

Product NDC
62332-728
Requested package NDC
62332-728-90
11-digit product format
623320728
Labeler code
62332
Product ID
62332-728_3e0914c5-051a-45fb-868f-3359e9ba76e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA216968
Marketing category
ANDA
Marketing start
2024-11-14
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
300 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
A216968-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08
A216968-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08
A216968-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08
A216968-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08
A216968-005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216968-001AB3
A216968-002AB3
A216968-003AB3
A216968-004AB3
A216968-005AB3

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 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A216968-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0884e616aacf4f…
2026-09-14 22:38:342026-08A216968-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0884e616aacf4f…
2026-09-14 22:38:342026-08A216968-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0884e616aacf4f…
2026-09-14 22:38:342026-08A216968-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0884e616aacf4f…
2026-09-14 22:38:342026-08A216968-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0884e616aacf4f…
2026-08-18 06:07:402026-07A216968-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07A216968-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07A216968-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07A216968-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07A216968-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216968-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216968-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216968-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216968-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216968-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216968-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216968-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216968-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216968-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216968-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A216968-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216968-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216968-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216968-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216968-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216968-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216968-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216968-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216968-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216968-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216968-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216968-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216968-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216968-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216968-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216968-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216968-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216968-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216968-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216968-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32024-11-0803ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216968-001AB3184e616aacf4f…
2026-09-14 22:38:342026-08A216968-002AB3184e616aacf4f…
2026-09-14 22:38:342026-08A216968-003AB3184e616aacf4f…
2026-09-14 22:38:342026-08A216968-004AB3184e616aacf4f…
2026-09-14 22:38:342026-08A216968-005AB3184e616aacf4f…
2026-08-18 06:07:402026-07A216968-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A216968-002AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A216968-003AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A216968-004AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A216968-005AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216968-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216968-002AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216968-003AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216968-004AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216968-005AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216968-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216968-002AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216968-003AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216968-004AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216968-005AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216968-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216968-002AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216968-003AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216968-004AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216968-005AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216968-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216968-002AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216968-003AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216968-004AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216968-005AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216968-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216968-002AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216968-003AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216968-004AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216968-005AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216968-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216968-002AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216968-003AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216968-004AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216968-005AB3103ed91905a0d…

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 HYDROCHLORIDE300 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
ac9aa10d-cd52-4ac9-a01d-e3cbf14d4913Available 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
62332-728-30Diltiazem Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307
62332-728-90Diltiazem Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE907
62332-728-91Diltiazem Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-728DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS INC.]5Current NDC, 3 package rows20241228_ac9aa10d-cd52-4ac9-a01d-e3cbf14d4913.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 HYDROCHLORIDEAlembic Pharmaceuticals Inc.ac9aa10d-cd52-4ac9-a01d-e3cbf14d49132025-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216968
application number: ANDA216968
ndc (package): 62332-728-90
ndc (product): 62332-728
ndc11 (package): 62332072890
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Limitedd9c5c1ed-1a9d-494c-b798-9da09ba1fe1b2024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216968
application number: ANDA216968

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSNac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSNac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSNac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCDac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCDac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSYac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYac9aa10d-cd52-4ac9-a01d-e3cbf14d49137
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSYac9aa10d-cd52-4ac9-a01d-e3cbf14d49137

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-728-906233207289090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-728-90) 2024-11-14NoNoCurrent