Diltiazem Hydrochloride

Product NDC
50090-0451
Requested package NDC
50090-0451-0
11-digit product format
500900451
Labeler code
50090
Product ID
50090-0451_6113069e-e767-42d1-a59a-5001924df02c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074185
Marketing category
ANDA
Marketing start
1995-12-22
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
60 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-045150090-0451-0DDiscontinued by firm2026-08-11

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074185-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB1995-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074185-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB1995-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074185-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB1995-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074185-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB1995-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074185-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB1995-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074185-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB1995-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074185-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB1995-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074185-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB1995-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074185-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB1995-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074185-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB1995-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074185-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB1995-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074185-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB1995-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074185-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB1995-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074185-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB1995-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074185-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB1995-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074185-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB1995-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074185-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB1995-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074185-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB1995-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074185-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB1995-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074185-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB1995-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074185-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB1995-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074185-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB1995-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074185-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB1995-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074185-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB1995-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074185-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB1995-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074185-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB1995-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074185-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB1995-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074185-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB1995-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074185-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB1995-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074185-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB1995-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074185-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB1995-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074185-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB1995-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074185-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB1995-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074185-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB1995-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074185-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB1995-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074185-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB1995-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074185-001DILTIAZEM HYDROCHLORIDE30MGTABLET / ORALAB1995-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074185-002DILTIAZEM HYDROCHLORIDE60MGTABLET / ORALAB1995-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074185-003DILTIAZEM HYDROCHLORIDE90MGTABLET / ORALAB1995-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074185-004DILTIAZEM HYDROCHLORIDE120MGTABLET / ORALAB1995-05-31d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074185-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074185-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074185-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074185-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074185-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074185-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074185-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074185-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074185-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074185-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074185-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074185-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074185-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074185-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074185-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074185-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074185-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074185-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074185-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074185-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074185-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074185-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074185-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074185-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074185-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074185-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074185-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074185-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074185-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074185-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074185-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074185-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074185-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074185-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074185-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074185-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074185-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074185-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074185-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074185-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Diltiazem Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE60 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
831103Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e99e1446-9c85-478c-9e23-a5f4104bbd22Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0451-0Diltiazem Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10019
50090-0451-2Diltiazem Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3019
50090-0451-3Diltiazem Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0451-2EA - Each50090-0451d3c2d53c-0b01-4236-b551-4915fd9aedda12018-09-05
50090-0451-3EA - Each50090-0451f5ba8b47-7bdb-4630-b76f-086954be72b012018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0451DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 3 package rows20231002_e99e1446-9c85-478c-9e23-a5f4104bbd22.zip

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 · 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
ndc (package): 50090-0451-0
ndc (product): 50090-0451
ndc11 (package): 50090045100
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831103dilTIAZem hydrochloride 60 MG Oral TabletPSNe99e1446-9c85-478c-9e23-a5f4104bbd2219
831103diltiazem hydrochloride 60 MG Oral TabletSCDe99e1446-9c85-478c-9e23-a5f4104bbd2219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0451-050090045100100 TABLET, FILM COATED in 1 BOTTLE (50090-0451-0) 2018-10-250000-00-00NoNoCurrent