Diltiazem Hydrochloride

Product NDC
63629-2158
11-digit product format
636292158
Labeler code
63629
Product ID
63629-2158_8549aafa-d9c8-4bbe-ad27-6eeb4d2c366d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074984
Marketing category
ANDA
Marketing start
2015-10-01
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074984-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20
A074984-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20
A074984-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20
A074984-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074984-001AB3
A074984-002AB3
A074984-003AB3
A074984-004AB3

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074984-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2084e616aacf4f…
2026-09-14 22:38:342026-08A074984-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2084e616aacf4f…
2026-09-14 22:38:342026-08A074984-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2084e616aacf4f…
2026-09-14 22:38:342026-08A074984-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2084e616aacf4f…
2026-08-18 06:07:402026-07A074984-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A074984-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A074984-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A074984-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074984-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074984-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074984-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074984-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074984-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074984-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074984-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074984-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074984-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074984-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074984-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074984-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074984-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074984-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074984-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074984-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074984-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074984-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074984-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074984-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074984-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074984-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074984-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074984-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074984-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074984-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074984-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074984-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074984-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074984-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074984-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074984-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31999-12-205bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A074984-001AB3184e616aacf4f…
2026-09-14 22:38:342026-08A074984-002AB3184e616aacf4f…
2026-09-14 22:38:342026-08A074984-003AB3184e616aacf4f…
2026-09-14 22:38:342026-08A074984-004AB3184e616aacf4f…
2026-08-18 06:07:402026-07A074984-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A074984-002AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A074984-003AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A074984-004AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074984-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074984-002AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074984-003AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074984-004AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074984-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074984-002AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074984-003AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074984-004AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074984-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074984-002AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074984-003AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074984-004AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074984-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074984-002AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074984-003AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074984-004AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074984-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074984-002AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074984-003AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074984-004AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074984-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074984-002AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074984-003AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074984-004AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074984-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074984-002AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074984-003AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074984-004AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074984-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074984-002AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074984-003AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074984-004AB315bbf6a4d5a75…

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
Brand name suffix
Extended-Release
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
830837Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a6Available 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
63629-2158-1Diltiazem HydrochlorideExtended-Release30 in 1 BOTTLECAPSULE, COATED, EXTENDED RELEAS30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2158-1EA - Each63629-2158c4d9e320-c3a9-4aad-9389-7dd025a2515012021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2158DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240111_2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a6.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackfb6a6199-bb70-476e-a2a2-b7594c9c001a2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074984
application number: ANDA074984
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEAmerican Health Packaging11b43a17-8038-462b-8902-259431ad52562026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074984
application number: ANDA074984
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackfe7ca564-16b8-4c54-aa09-3e2ed0c2596a2024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074984
application number: ANDA074984
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackde2a0c48-7fc4-4760-b465-a79299876e6e2024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074984
application number: ANDA074984
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack74232d69-1a8c-449d-8e8e-85488e6cc8f82024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074984
application number: ANDA074984
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack0e9b4421-bc43-4a77-b49b-e3f53d1e0f012024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074984
application number: ANDA074984
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacka6cc3b99-2c0f-4d8a-8393-ec042ed7c8922024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074984
application number: ANDA074984
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a62024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074984
application number: ANDA074984
ndc (product): 63629-2158
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack762c3007-b22f-4d35-87b4-191fec8b3a9a2023-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074984
application number: ANDA074984
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackeed8cfeb-6ec7-4914-b8e0-a5c3d623c9a42023-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074984
application number: ANDA074984

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a6102
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a6102
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a6102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2158-16362921580130 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (63629-2158-1) 2021-03-100000-00-00NoNoCurrent