Diltiazem Hydrochloride

Product NDC
0409-1171
11-digit product format
004091171
Labeler code
0409
Product ID
0409-1171_5e51477c-3362-4911-b807-aea83af23c27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA074941
Marketing category
ANDA
Marketing start
2006-05-05
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-1171DDiscontinued by firm2026-10-05
excluded packagepackage0409-11710409-1171-01DDiscontinued by firm2026-10-05
excluded packagepackage0409-11710409-1171-02DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-1171-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-1171-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-1171-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-1171-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-1171-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-1171-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-1171-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-1171-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-1171-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-1171-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-1171-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-1171-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-1171-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-1171-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-1171-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-1171-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-1171-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-1171-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-1171-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-1171-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-1171-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-1171-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-1171-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-1171-02557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A074941-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTION1998-04-15

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTION1998-04-1584e616aacf4f…
2026-08-18 06:07:402026-07A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTION1998-04-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTION1998-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTION1998-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-153f01610625f2…
2019-09-15 20:21 UTC2019-09A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074941-001DILTIAZEM HYDROCHLORIDE5MG/MLINJECTABLE / INJECTIONAP1998-04-15f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A074941-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074941-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074941-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074941-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074941-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074941-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074941-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074941-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074941-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074941-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074941-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074941-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074941-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074941-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074941-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074941-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074941-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074941-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074941-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A074941-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074941-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074941-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074941-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A074941-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074941-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074941-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074941-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074941-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074941-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074941-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074941-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074941-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074941-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074941-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074941-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074941-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074941-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074941-001AP1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0409-1171-01Diltiazem Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1021
0409-1171-02Diltiazem Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1021
0409-1171-11Diltiazem Hydrochloride5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION521
0409-1171-12Diltiazem Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1171-01ML - Milliliter0409-1171a674d9b6-672e-48b1-9840-dca375d809ad12012-07-24
0409-1171-02ML - Milliliter0409-11710c107007-95f6-477b-978e-a0a9a46f43b012012-07-24
0409-1171-11ML - Milliliter0409-1171dd97530d-903b-478c-870c-46fc3d95dc2c12019-07-02
0409-1171-12ML - Milliliter0409-11711fb0fa7b-cff1-4f07-8ea5-a860b7646a5d12019-07-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1171DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION DILTIAZEM HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]20Legacy NDC, 4 package rows20230118_bba03666-ff4f-4bf6-fa92-78e1ec2d9073.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHospira, Inc.bba03666-ff4f-4bf6-fa92-78e1ec2d90732026-05-24Warnings, Adverse reactionsExact identifier
ndc (product): 0409-1171

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791240dilTIAZem hydrochloride 100 MG InjectionPSNbba03666-ff4f-4bf6-fa92-78e1ec2d907321
1791240diltiazem hydrochloride 100 MG InjectionSCDbba03666-ff4f-4bf6-fa92-78e1ec2d907321
1791230diltiazem hydrochloride 5 MG/ML InjectionSCDbba03666-ff4f-4bf6-fa92-78e1ec2d907321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1171-010040911710110 VIAL, SINGLE-DOSE in 1 CARTON (0409-1171-01) > 5 mL in 1 VIAL, SINGLE-DOSE (0409-1171-11) 2006-09-130000-00-00NoNoCurrent
0409-1171-020040911710210 VIAL, SINGLE-DOSE in 1 CARTON (0409-1171-02) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-1171-12) 2006-05-050000-00-00NoNoCurrent
0409-1171-11004091171115 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0409-1171-120040911711210 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical