FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
25021-319
11-digit product format
250210319
Labeler code
25021
Product ID
25021-319_13a2c20f-bf6f-4dad-938e-6f4ff99a689a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
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

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 Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui1791229, 1791232, 1791233

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
25021-319-05Diltiazem Hydrochloride5 mL in 1 VIALINJECTION, SOLUTION51
25021-319-05Diltiazem Hydrochloride10 in 1 CARTONINJECTION, SOLUTION101
25021-319-10Diltiazem Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION101
25021-319-10Diltiazem Hydrochloride10 in 1 CARTONINJECTION, SOLUTION101
25021-319-25Diltiazem Hydrochloride25 mL in 1 VIALINJECTION, SOLUTION251
25021-319-25Diltiazem Hydrochloride10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-319-05ML - Milliliter25021-319237f639c-8c2a-4deb-b6fb-e94deec9e42112024-08-12
25021-319-10ML - Milliliter25021-3199284fd46-4f59-4c36-80a2-ebb3aff63b8712024-08-12
25021-319-25ML - Milliliter25021-319bf44e8c3-e7c7-4c85-8261-5c164b67bb3f12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-319DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 6 package rows20240601_9d51c0f6-26b7-4220-83fb-4e736b289e64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791233dilTIAZem hydrochloride 125 MG in 25 mL InjectionPSN9d51c0f6-26b7-4220-83fb-4e736b289e641
1791229dilTIAZem hydrochloride 25 MG in 5 mL InjectionPSN3f2942d7-f4d0-2d77-e063-6294a90a74ad1
1791229dilTIAZem hydrochloride 25 MG in 5 mL InjectionPSN41d75325-d935-ba54-e063-6394a90aade21
1791229dilTIAZem hydrochloride 25 MG in 5 mL InjectionPSN9d51c0f6-26b7-4220-83fb-4e736b289e641
1791232dilTIAZem hydrochloride 50 MG in 10 mL InjectionPSN9d51c0f6-26b7-4220-83fb-4e736b289e641
179123210 ML diltiazem hydrochloride 5 MG/ML InjectionSCD9d51c0f6-26b7-4220-83fb-4e736b289e641
179123325 ML diltiazem hydrochloride 5 MG/ML InjectionSCD9d51c0f6-26b7-4220-83fb-4e736b289e641
17912295 ML diltiazem hydrochloride 5 MG/ML InjectionSCD3f2942d7-f4d0-2d77-e063-6294a90a74ad1
17912295 ML diltiazem hydrochloride 5 MG/ML InjectionSCD41d75325-d935-ba54-e063-6394a90aade21
17912295 ML diltiazem hydrochloride 5 MG/ML InjectionSCD9d51c0f6-26b7-4220-83fb-4e736b289e641
1791233diltiazem hydrochloride 125 MG per 25 ML InjectionSY9d51c0f6-26b7-4220-83fb-4e736b289e641
1791229diltiazem hydrochloride 25 MG per 5 ML InjectionSY3f2942d7-f4d0-2d77-e063-6294a90a74ad1
1791229diltiazem hydrochloride 25 MG per 5 ML InjectionSY41d75325-d935-ba54-e063-6394a90aade21
1791229diltiazem hydrochloride 25 MG per 5 ML InjectionSY9d51c0f6-26b7-4220-83fb-4e736b289e641
1791232diltiazem hydrochloride 50 MG per 10 ML InjectionSY9d51c0f6-26b7-4220-83fb-4e736b289e641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-319-052502103190510 VIAL in 1 CARTON (25021-319-05) / 5 mL in 1 VIAL10 vial2024-06-01NoNoCurrent
25021-319-102502103191010 VIAL in 1 CARTON (25021-319-10) / 10 mL in 1 VIAL10 vial2024-06-01NoNoCurrent
25021-319-252502103192510 VIAL in 1 CARTON (25021-319-25) / 25 mL in 1 VIAL10 vial2024-06-01NoNoCurrent