FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
50742-565
11-digit product format
507420565
Labeler code
50742
Product ID
50742-565_3dd3b71c-60fb-45a2-866e-7761f1c48aa3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA218032
Marketing category
ANDA
Marketing start
2025-07-03
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
90 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218032-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-02
A218032-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-02
A218032-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A218032-001AB1
A218032-002AB1
A218032-003AB1

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
2026-09-14 22:38:342026-08A218032-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-0284e616aacf4f…
2026-09-14 22:38:342026-08A218032-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-0284e616aacf4f…
2026-09-14 22:38:342026-08A218032-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-0284e616aacf4f…
2026-08-18 06:07:402026-07A218032-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-02caaa826d4ba7…
2026-08-18 06:07:402026-07A218032-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-02caaa826d4ba7…
2026-08-18 06:07:402026-07A218032-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218032-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218032-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218032-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218032-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218032-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218032-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A218032-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218032-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218032-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-026a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218032-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218032-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218032-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB12025-07-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218032-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A218032-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A218032-003AB1184e616aacf4f…
2026-08-18 06:07:402026-07A218032-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A218032-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A218032-003AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218032-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218032-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218032-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218032-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218032-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218032-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218032-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218032-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218032-003AB116a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218032-001AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218032-002AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218032-003AB11a50c72e98297…

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 HYDROCHLORIDE90 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
830865Internal RxNorm lookup
830869Internal RxNorm lookup
830872Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
64401d2a-bd5b-43fd-879a-e9d16345e827Available 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
50742-565-01Diltiazem Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE1001
50742-565-05Diltiazem Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-565-01EA - Each50742-565d693b73b-f442-486a-b023-d6ebde5027eb12025-10-14

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEIngenus Pharmaceuticals, LLC64401d2a-bd5b-43fd-879a-e9d16345e8272025-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218032
application number: ANDA218032
ndc (product): 50742-565

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830872dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral CapsulePSN64401d2a-bd5b-43fd-879a-e9d16345e8271
830865dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral CapsulePSN64401d2a-bd5b-43fd-879a-e9d16345e8271
830869dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral CapsulePSN64401d2a-bd5b-43fd-879a-e9d16345e8271
83087212 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD64401d2a-bd5b-43fd-879a-e9d16345e8271
83086512 HR diltiazem hydrochloride 60 MG Extended Release Oral CapsuleSCD64401d2a-bd5b-43fd-879a-e9d16345e8271
83086912 HR diltiazem hydrochloride 90 MG Extended Release Oral CapsuleSCD64401d2a-bd5b-43fd-879a-e9d16345e8271
830872diltiazem hydrochloride 120 MG 12 HR Extended Release Oral CapsuleSY64401d2a-bd5b-43fd-879a-e9d16345e8271
830865diltiazem hydrochloride 60 MG 12 HR Extended Release Oral CapsuleSY64401d2a-bd5b-43fd-879a-e9d16345e8271
830869diltiazem hydrochloride 90 MG 12 HR Extended Release Oral CapsuleSY64401d2a-bd5b-43fd-879a-e9d16345e8271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50742-565-0150742056501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-565-01) 2025-07-03NoNoCurrent
50742-565-0550742056505500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-565-05) 2025-07-03NoNoCurrent