Diltiazem Hydrochloride

Product NDC
71872-7345
11-digit product format
718727345
Labeler code
71872
Product ID
71872-7345_41d74885-4313-bdcd-e063-6394a90aea00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA074617
Marketing category
ANDA
Marketing start
2024-06-01
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
5 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074617-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074617-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-283f01610625f2…
2019-09-15 20:21 UTC2019-09A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074617-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAPRS1996-02-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074617-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074617-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074617-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074617-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074617-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074617-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074617-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074617-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074617-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074617-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074617-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074617-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074617-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074617-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074617-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074617-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074617-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074617-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074617-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074617-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074617-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A074617-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074617-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074617-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074617-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A074617-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074617-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074617-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074617-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074617-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074617-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074617-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074617-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074617-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074617-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074617-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074617-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074617-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074617-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074617-001AP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE5 mg/mL

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
1791229Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
41d75325-d935-ba54-e063-6394a90aade2Available 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
71872-7345-1Diltiazem Hydrochloride1 in 1 BAGINJECTION, SOLUTION11
71872-7345-1Diltiazem Hydrochloride5 mL in 1 VIALINJECTION, SOLUTION51

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMedical Purchasing Solutions, LLC41d75325-d935-ba54-e063-6394a90aade22025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074617
application number: ANDA074617
ndc (product): 71872-7345
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEProPharma Distribution3f2942d7-f4d0-2d77-e063-6294a90a74ad2025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074617
application number: ANDA074617
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESagent Pharmaceuticals9d51c0f6-26b7-4220-83fb-4e736b289e642024-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074617
application number: ANDA074617

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791229dilTIAZem hydrochloride 25 MG in 5 mL InjectionPSN41d75325-d935-ba54-e063-6394a90aade21
17912295 ML diltiazem hydrochloride 5 MG/ML InjectionSCD41d75325-d935-ba54-e063-6394a90aade21
1791229diltiazem hydrochloride 25 MG per 5 ML InjectionSY41d75325-d935-ba54-e063-6394a90aade21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71872-7345-1718727345011 VIAL in 1 BAG (71872-7345-1) / 5 mL in 1 VIAL1 vial2025-03-12NoNoCurrent