FDA.reportPublic FDA data

DILTIAZEM HCI

Product NDC
51662-1335
11-digit product format
516621335
Labeler code
51662
Product ID
51662-1335_f2a0ac76-9d93-eaad-e053-2a95a90a4d67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DILTIAZEM HCI
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA078538
Marketing category
ANDA
Marketing start
2018-12-21
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
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 HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui1791229

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1335-12020-02-07C16284748780-19d75b9d0-14b9-f424-e053-dadaa90a57ceDILTIAZEM HCI INJECTION 25mg/5mL (5 mg/mL) 5mL VIAL
51662-1335-12020-01-31C16284748780-19d75b9d0-14b9-f424-e053-dadaa90a57ceDILTIAZEM HCI INJECTION 25mg/5mL (5 mg/mL) 5mL VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1335-1DILTIAZEM HCI5 mL in 1 VIALINJECTION55
51662-1335-2DILTIAZEM HCI5 mL in 1 VIALINJECTION55
51662-1335-2DILTIAZEM HCI1 in 1 POUCHINJECTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1335DILTIAZEM HCI INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]5Current NDC, Legacy NDC, 3 package rows20230120_7d8e8b1e-f67b-57d2-e053-2991aa0a8d12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791229dilTIAZem hydrochloride 25 MG in 5 mL InjectionPSN7d8e8b1e-f67b-57d2-e053-2991aa0a8d125
17912295 ML diltiazem hydrochloride 5 MG/ML InjectionSCD7d8e8b1e-f67b-57d2-e053-2991aa0a8d125
1791229diltiazem hydrochloride 25 MG per 5 ML InjectionSY7d8e8b1e-f67b-57d2-e053-2991aa0a8d125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1335-1516621335015 mL in 1 VIAL (51662-1335-1) 5 ml2018-12-210000-00-00NoNoCurrent
51662-1335-2516621335021 VIAL in 1 POUCH (51662-1335-2) / 5 mL in 1 VIAL1 vial2023-01-19NoNoCurrent