FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
70518-2451
11-digit product format
705182451
Labeler code
70518
Product ID
70518-2451_f19c0138-c1c6-9420-e053-2995a90a0e59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride Extended-Release Tablets
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA021392
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-11-25
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
240 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2451DDiscontinued by firm2026-08-03
excluded packagepackage70518-245170518-2451-0DDiscontinued by firm2026-08-03
excluded packagepackage70518-245170518-2451-1DDiscontinued by firm2026-08-03
excluded packagepackage70518-245170518-2451-2DDiscontinued by firm2026-08-03

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2451-0EA - Each70518-24516b672434-fe1c-426e-9cb6-448b587a330012024-04-05
70518-2451-2EA - Each70518-24516f3c4973-42ed-4995-b270-42a27d9be8e112024-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2451-07051824510090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2451-0) 2019-11-250000-00-00NoNoCurrent
70518-2451-27051824510290 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2451-2) 2022-01-040000-00-00NoNoCurrent