FDA.reportPublic FDA data

DILTIAZEM HCI

Product NDC
51662-1457
11-digit product format
516621457
Labeler code
51662
Product ID
51662-1457_132cd9f9-a36c-4e35-e063-6294a90aaa17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DILTIAZEM HCI
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA075853
Marketing category
ANDA
Marketing start
2019-12-15
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
100 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

Additional Listing Data#

Finished product
Yes
Brand name base
DILTIAZEM HCI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui1791240

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
51662-1457-1DILTIAZEM HCI1 in 1 VIAL, PATENT DELIVERY SYSTEMINJECTION, POWDER, LYOPHILIZED,15
51662-1457-2DILTIAZEM HCI1 in 1 VIAL, PATENT DELIVERY SYSTEMINJECTION, POWDER, LYOPHILIZED,15
51662-1457-2DILTIAZEM HCI1 in 1 POUCHINJECTION, POWDER, LYOPHILIZED,15
51662-1457-3DILTIAZEM HCI10 in 1 CASEINJECTION, POWDER, LYOPHILIZED,105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1457DILTIAZEM HCI INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]5Current NDC, Legacy NDC, 4 package rows20240310_99c5813f-1ffe-0eaa-e053-2a95a90a751b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791240dilTIAZem hydrochloride 100 MG InjectionPSN99c5813f-1ffe-0eaa-e053-2a95a90a751b5
1791240diltiazem hydrochloride 100 MG InjectionSCD99c5813f-1ffe-0eaa-e053-2a95a90a751b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1457-1516621457011 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (51662-1457-1) 2019-12-150000-00-00NoNoCurrent
51662-1457-2516621457021 in 1 VIAL, PATENT DELIVERY SYSTEMHistorical
51662-1457-35166214570310 POUCH in 1 CASE (51662-1457-3) / 1 VIAL, PATENT DELIVERY SYSTEM in 1 POUCH (51662-1457-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM10 pouch2022-12-110000-00-00NoNoCurrent