FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
0093-0318
11-digit product format
000930318
Labeler code
0093
Product ID
0093-0318_eb4d8470-1f38-42c6-a511-8383066ed454
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA074185
Marketing category
ANDA
Marketing start
1995-12-22
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
30 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074185-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB1995-05-31
A074185-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB1995-05-31
A074185-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB1995-05-31
A074185-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB1995-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A074185-001AB
A074185-002AB
A074185-003AB
A074185-004AB

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 22:54:322026-06A074185-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB1995-05-31a50c72e98297…
2026-08-01 22:54:322026-06A074185-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB1995-05-31a50c72e98297…
2026-08-01 22:54:322026-06A074185-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB1995-05-31a50c72e98297…
2026-08-01 22:54:322026-06A074185-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB1995-05-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074185-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A074185-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A074185-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A074185-004AB1a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutionse99e1446-9c85-478c-9e23-a5f4104bbd222026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074185
application number: ANDA074185
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENorthwind Health Company, LLCf29febd6-5a27-eb83-e053-2a95a90a5b7d2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074185
application number: ANDA074185
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAmerican Health Packaging14869f9e-6a66-4f75-b0fc-4d808b1ee85e2025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074185
application number: ANDA074185
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDETeva Pharmaceuticals USA, Inc.69ca7cae-fdf3-413a-900b-95cf6e9e7b632025-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074185
application number: ANDA074185
ndc (product): 0093-0318
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs74620be9-5120-491a-a171-e50612c065412024-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074185
application number: ANDA074185
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack6ca6a648-fc67-4cf8-a1f7-787c9574e3a12024-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074185
application number: ANDA074185
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEProficient Rx LPa24255a3-88b1-47ef-90fc-51619a1c5a632023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074185
application number: ANDA074185

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE30 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
831054Internal RxNorm lookup
831102Internal RxNorm lookup
831103Internal RxNorm lookup
833217Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
69ca7cae-fdf3-413a-900b-95cf6e9e7b63Available 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
0093-0318-01Diltiazem Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10014
0093-0318-05Diltiazem Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0318-01EA - Each0093-031804450f0e-6e5c-43ba-8be4-1f4d56f8a9af12012-07-24
0093-0318-05EA - Each0093-031865acb435-53f1-49e8-b122-f22ab0b09b1112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
DILTIAZEMACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZDILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]7
Diltiazem HydrochlorideACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
DiltiazemACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DILTIAZEM HYDROCHLORIDE TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDILTIAZEM HYDROCHLORIDE TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30DILTIAZEM HYDROCHLORIDE TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADILTIAZEM HYDROCHLORIDE TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDILTIAZEM HYDROCHLORIDE TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EDILTIAZEM HYDROCHLORIDE TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-0318DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]13Current NDC, Legacy NDC, 2 package rows20210429_69ca7cae-fdf3-413a-900b-95cf6e9e7b63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833217dilTIAZem hydrochloride 30 MG Oral TabletPSN6ca6a648-fc67-4cf8-a1f7-787c9574e3a1100
833217diltiazem hydrochloride 30 MG Oral TabletSCD6ca6a648-fc67-4cf8-a1f7-787c9574e3a1100
831102dilTIAZem HCl 90 MG Oral TabletPSN69ca7cae-fdf3-413a-900b-95cf6e9e7b6314
831054dilTIAZem hydrochloride 120 MG Oral TabletPSN69ca7cae-fdf3-413a-900b-95cf6e9e7b6314
833217dilTIAZem hydrochloride 30 MG Oral TabletPSN69ca7cae-fdf3-413a-900b-95cf6e9e7b6314
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN69ca7cae-fdf3-413a-900b-95cf6e9e7b6314
831054diltiazem hydrochloride 120 MG Oral TabletSCD69ca7cae-fdf3-413a-900b-95cf6e9e7b6314
833217diltiazem hydrochloride 30 MG Oral TabletSCD69ca7cae-fdf3-413a-900b-95cf6e9e7b6314
831103diltiazem hydrochloride 60 MG Oral TabletSCD69ca7cae-fdf3-413a-900b-95cf6e9e7b6314
831102diltiazem hydrochloride 90 MG Oral TabletSCD69ca7cae-fdf3-413a-900b-95cf6e9e7b6314
833217dilTIAZem hydrochloride 30 MG Oral TabletPSN74620be9-5120-491a-a171-e50612c065418
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN74620be9-5120-491a-a171-e50612c065418
833217diltiazem hydrochloride 30 MG Oral TabletSCD74620be9-5120-491a-a171-e50612c065418
831103diltiazem hydrochloride 60 MG Oral TabletSCD74620be9-5120-491a-a171-e50612c065418
833217dilTIAZem hydrochloride 30 MG Oral TabletPSN14869f9e-6a66-4f75-b0fc-4d808b1ee85e4
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN14869f9e-6a66-4f75-b0fc-4d808b1ee85e4
833217diltiazem hydrochloride 30 MG Oral TabletSCD14869f9e-6a66-4f75-b0fc-4d808b1ee85e4
831103diltiazem hydrochloride 60 MG Oral TabletSCD14869f9e-6a66-4f75-b0fc-4d808b1ee85e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-0318-0100093031801100 TABLET, FILM COATED in 1 BOTTLE (0093-0318-01) 1995-12-220000-00-00NoNoCurrent
0093-0318-0500093031805500 TABLET, FILM COATED in 1 BOTTLE (0093-0318-05) 1995-12-280000-00-00NoNoCurrent