FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
68682-709
11-digit product format
686820709
Labeler code
68682
Product ID
68682-709_9c3468f2-1199-4180-9e57-089b5353251a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride Extended-Release Tablets
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
NDA021392
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-02-06
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
420 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 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021392-001CARDIZEM LADILTIAZEM HYDROCHLORIDE120MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06
N021392-002CARDIZEM LADILTIAZEM HYDROCHLORIDE180MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06
N021392-003CARDIZEM LADILTIAZEM HYDROCHLORIDE240MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06
N021392-004CARDIZEM LADILTIAZEM HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06
N021392-005CARDIZEM LADILTIAZEM HYDROCHLORIDE360MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06
N021392-006CARDIZEM LADILTIAZEM HYDROCHLORIDE420MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
N021392-001AB
N021392-002AB
N021392-003AB
N021392-004AB
N021392-005AB
N021392-006AB

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 22:54:322026-06N021392-001CARDIZEM LA120MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06a50c72e98297…
2026-08-01 22:54:322026-06N021392-002CARDIZEM LA180MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06a50c72e98297…
2026-08-01 22:54:322026-06N021392-003CARDIZEM LA240MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06a50c72e98297…
2026-08-01 22:54:322026-06N021392-004CARDIZEM LA300MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06a50c72e98297…
2026-08-01 22:54:322026-06N021392-005CARDIZEM LA360MGTABLET, EXTENDED RELEASE / ORALABRLD2003-02-06a50c72e98297…
2026-08-01 22:54:322026-06N021392-006CARDIZEM LA420MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2003-02-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021392-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021392-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N021392-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N021392-004AB1a50c72e98297…
2026-08-01 22:54:322026-06N021392-005AB1a50c72e98297…
2026-08-01 22:54:322026-06N021392-006AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cardizem LADILTIAZEM HYDROCHLORIDEBausch Health US LLC3e180dc7-c871-4efc-8755-cae882976c8d2025-11-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 021392
application number: NDA021392
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETSOceanside Pharmaceuticals73b3607a-99d0-44d8-92ef-0074684c9d7d2025-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021392
application number: NDA021392
ndc (product): 68682-709

Additional Listing Data#

Finished product
Yes
Brand name base
Diltiazem Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE420 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
830874Internal RxNorm lookup
830877Internal RxNorm lookup
830879Internal RxNorm lookup
830882Internal RxNorm lookup
830897Internal RxNorm lookup
830900Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
73b3607a-99d0-44d8-92ef-0074684c9d7dAvailable 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
68682-709-30Diltiazem Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3010
68682-709-90Diltiazem Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-709-30EA - Each68682-709d7a6c411-22fb-4d21-8476-ea5d2d267e7912014-04-03
68682-709-90EA - Each68682-709f378fca2-0fb8-428e-b410-d6e527a2f6fc12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diltiazem HydrochlorideACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
DiltiazemACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)INACTIVE INGREDIENTP2OM2Q86BIDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KYDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
polydextroseINACTIVE INGREDIENTVH2XOU12IEDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
sucrose stearateINACTIVE INGREDIENT274KW0O50MDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
talcINACTIVE INGREDIENT7SEV7J4R1UDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-709DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]9Current NDC, Legacy NDC, 2 package rows20230331_73b3607a-99d0-44d8-92ef-0074684c9d7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830874dilTIAZem hydrochloride 120 MG 24HR Extended Release Oral TabletPSN73b3607a-99d0-44d8-92ef-0074684c9d7d10
830877dilTIAZem hydrochloride 180 MG 24HR Extended Release Oral TabletPSN73b3607a-99d0-44d8-92ef-0074684c9d7d10
830879dilTIAZem hydrochloride 240 MG 24HR Extended Release Oral TabletPSN73b3607a-99d0-44d8-92ef-0074684c9d7d10
830882dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral TabletPSN73b3607a-99d0-44d8-92ef-0074684c9d7d10
830897dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral TabletPSN73b3607a-99d0-44d8-92ef-0074684c9d7d10
830900dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral TabletPSN73b3607a-99d0-44d8-92ef-0074684c9d7d10
83087424 HR diltiazem hydrochloride 120 MG Extended Release Oral TabletSCD73b3607a-99d0-44d8-92ef-0074684c9d7d10
83087724 HR diltiazem hydrochloride 180 MG Extended Release Oral TabletSCD73b3607a-99d0-44d8-92ef-0074684c9d7d10
83087924 HR diltiazem hydrochloride 240 MG Extended Release Oral TabletSCD73b3607a-99d0-44d8-92ef-0074684c9d7d10
83088224 HR diltiazem hydrochloride 300 MG Extended Release Oral TabletSCD73b3607a-99d0-44d8-92ef-0074684c9d7d10
83089724 HR diltiazem hydrochloride 360 MG Extended Release Oral TabletSCD73b3607a-99d0-44d8-92ef-0074684c9d7d10
83090024 HR diltiazem hydrochloride 420 MG Extended Release Oral TabletSCD73b3607a-99d0-44d8-92ef-0074684c9d7d10
830874diltiazem hydrochloride 120 MG 24 HR Extended Release Oral TabletSY73b3607a-99d0-44d8-92ef-0074684c9d7d10
830877diltiazem hydrochloride 180 MG 24 HR Extended Release Oral TabletSY73b3607a-99d0-44d8-92ef-0074684c9d7d10
830879diltiazem hydrochloride 240 MG 24 HR Extended Release Oral TabletSY73b3607a-99d0-44d8-92ef-0074684c9d7d10
830882diltiazem hydrochloride 300 MG 24 HR Extended Release Oral TabletSY73b3607a-99d0-44d8-92ef-0074684c9d7d10
830897diltiazem hydrochloride 360 MG 24 HR Extended Release Oral TabletSY73b3607a-99d0-44d8-92ef-0074684c9d7d10
830900diltiazem hydrochloride 420 MG 24 HR Extended Release Oral TabletSY73b3607a-99d0-44d8-92ef-0074684c9d7d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-709-306868207093030 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-709-30) 2014-02-060000-00-00NoNoCurrent
68682-709-906868207099090 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-709-90) 2014-02-060000-00-00NoNoCurrent