FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
33342-521
11-digit product format
333420521
Labeler code
33342
Product ID
33342-521_5ecb8ea4-5519-4246-8916-2d527fe0d760
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA218744
Marketing category
ANDA
Marketing start
2023-06-23
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A218744-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27
A218744-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27
A218744-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27
A218744-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27
A218744-005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218744-001AB3
A218744-002AB3
A218744-003AB3
A218744-004AB3
A218744-005AB3

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A218744-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27c2088c7a36db…
2026-10-15 13:18:302026-09A218744-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27c2088c7a36db…
2026-10-15 13:18:302026-09A218744-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27c2088c7a36db…
2026-10-15 13:18:302026-09A218744-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27c2088c7a36db…
2026-10-15 13:18:302026-09A218744-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27c2088c7a36db…
2026-09-14 22:38:342026-08A218744-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-2784e616aacf4f…
2026-09-14 22:38:342026-08A218744-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-2784e616aacf4f…
2026-09-14 22:38:342026-08A218744-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-2784e616aacf4f…
2026-09-14 22:38:342026-08A218744-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-2784e616aacf4f…
2026-09-14 22:38:342026-08A218744-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-2784e616aacf4f…
2026-08-18 06:07:402026-07A218744-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07A218744-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07A218744-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07A218744-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07A218744-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218744-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218744-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218744-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218744-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218744-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32026-02-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A218744-001AB31c2088c7a36db…
2026-10-15 13:18:302026-09A218744-002AB31c2088c7a36db…
2026-10-15 13:18:302026-09A218744-003AB31c2088c7a36db…
2026-10-15 13:18:302026-09A218744-004AB31c2088c7a36db…
2026-10-15 13:18:302026-09A218744-005AB31c2088c7a36db…
2026-09-14 22:38:342026-08A218744-001AB3184e616aacf4f…
2026-09-14 22:38:342026-08A218744-002AB3184e616aacf4f…
2026-09-14 22:38:342026-08A218744-003AB3184e616aacf4f…
2026-09-14 22:38:342026-08A218744-004AB3184e616aacf4f…
2026-09-14 22:38:342026-08A218744-005AB3184e616aacf4f…
2026-08-18 06:07:402026-07A218744-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A218744-002AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A218744-003AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A218744-004AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A218744-005AB31caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218744-001AB31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218744-002AB31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218744-003AB31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218744-004AB31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218744-005AB31a50c72e98297…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE120 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
850566b1-0c8e-42bc-85fa-c8ee710f34baAvailable 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
33342-521-02Diltiazem Hydrochloride6 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE61
33342-521-07Diltiazem Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
33342-521-10Diltiazem Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSN850566b1-0c8e-42bc-85fa-c8ee710f34ba1
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD850566b1-0c8e-42bc-85fa-c8ee710f34ba1
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD850566b1-0c8e-42bc-85fa-c8ee710f34ba1
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD850566b1-0c8e-42bc-85fa-c8ee710f34ba1
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD850566b1-0c8e-42bc-85fa-c8ee710f34ba1
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCD850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY850566b1-0c8e-42bc-85fa-c8ee710f34ba1
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSY850566b1-0c8e-42bc-85fa-c8ee710f34ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-521-02333420521026 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (33342-521-02) 2023-06-23NoNoCurrent
33342-521-073334205210730 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-521-07) 2023-06-23NoNoCurrent
33342-521-103334205211090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-521-10) 2023-06-23NoNoCurrent