FDA.reportPublic FDA data

diltiazem hydrochloride

Product NDC
70518-3484
Requested package NDC
70518-3484-0
11-digit product format
705183484
Labeler code
70518
Product ID
70518-3484_4f1d1966-bc81-e48b-e063-6294a90ad352
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208783
Marketing category
ANDA
Marketing start
2022-08-19
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 1.

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
A208783-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14
A208783-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14
A208783-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14
A208783-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14
A208783-005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208783-001AB3
A208783-002AB3
A208783-003AB3
A208783-004AB3
A208783-005AB3

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
2026-08-01 22:54:322026-06A208783-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14a50c72e98297…
2026-08-01 22:54:322026-06A208783-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14a50c72e98297…
2026-08-01 22:54:322026-06A208783-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14a50c72e98297…
2026-08-01 22:54:322026-06A208783-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14a50c72e98297…
2026-08-01 22:54:322026-06A208783-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32019-06-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208783-001AB31a50c72e98297…
2026-08-01 22:54:322026-06A208783-002AB31a50c72e98297…
2026-08-01 22:54:322026-06A208783-003AB31a50c72e98297…
2026-08-01 22:54:322026-06A208783-004AB31a50c72e98297…
2026-08-01 22:54:322026-06A208783-005AB31a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackec928ee5-0809-4ba5-82ca-ecfed99ebb5a2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEREMEDYREPACK INC.5e935265-d0fc-4223-835f-72426eeea6c42026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
ndc (package): 70518-3484-0
ndc (product): 70518-3484
ndc11 (package): 70518348400
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEPreferred Pharmaceuticals Inc.3d594530-885f-45c7-b8a5-fd7e503ff83f2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacka469b24a-fbec-4a2d-8b4c-b62c2b2c66f62026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacke6d9397c-f8a2-42d6-88ca-55060b1d073a2025-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack9041cc05-29d2-41ca-a368-e953bf3443b52025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack0089fc7a-a7aa-4873-b699-39a1b21616ca2025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEIngenus Pharmaceuticals, LLC355f560a-8ebb-4661-ad74-2a22f707d7f82025-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
Diltiazem HCL ERDILTIAZEM HCL ERDirect_Rxf1ea85b2-ecd2-5867-e053-2a95a90a24dc2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs70f167a1-ec7f-4969-b446-166af3e52c052024-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208783
application number: ANDA208783

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
5e935265-d0fc-4223-835f-72426eeea6c4Available 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
70518-3484-0diltiazem hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3484DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 1 package rows20250423_5e935265-d0fc-4223-835f-72426eeea6c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN5e935265-d0fc-4223-835f-72426eeea6c45
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD5e935265-d0fc-4223-835f-72426eeea6c45
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY5e935265-d0fc-4223-835f-72426eeea6c45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3484-07051834840030 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-3484-0) 2022-08-190000-00-00NoNoCurrent