FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
70860-301
11-digit product format
708600301
Labeler code
70860
Product ID
70860-301_7fb9b2d0-abc0-4ec5-af4e-9db654c9ae3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA074617
Marketing category
ANDA
Marketing start
2019-12-15
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
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-301-052024-03-03C16284748780-11030e365-2434-111a-e063-dadaa90a10e20f02f0cf-d34c-4870-a293-e996132a5b89
70860-301-102024-03-03C16284748780-11030e365-2434-111a-e063-dadaa90a10e20f02f0cf-d34c-4870-a293-e996132a5b89
70860-301-252024-03-03C16284748780-11030e365-2434-111a-e063-dadaa90a10e20f02f0cf-d34c-4870-a293-e996132a5b89
70860-301-052024-01-30C16284748780-11030e365-2434-111a-e063-dadaa90a10e20f02f0cf-d34c-4870-a293-e996132a5b89
70860-301-102024-01-30C16284748780-11030e365-2434-111a-e063-dadaa90a10e20f02f0cf-d34c-4870-a293-e996132a5b89
70860-301-252024-01-30C16284748780-11030e365-2434-111a-e063-dadaa90a10e20f02f0cf-d34c-4870-a293-e996132a5b89

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-301-05ML - Milliliter70860-3011961b8b0-4637-4622-a0f9-9507ef742d0112020-02-13
70860-301-10ML - Milliliter70860-30110756b5f-9b7b-4622-84d2-b7835632823d12020-03-10
70860-301-25ML - Milliliter70860-30128b5dd64-ed50-4806-b5ad-f398bfe7b26212020-03-10
70860-301-41ML - Milliliter70860-3011cb245a9-a811-4f70-a97c-95a87692e71a12020-03-10
70860-301-42ML - Milliliter70860-3010b8e766b-923a-4a99-92f6-253ce08c093812020-03-10
70860-301-43ML - Milliliter70860-301a246aa87-af10-45ee-873f-aff41612628f12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-301DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]4Legacy NDC20250130_0f02f0cf-d34c-4870-a293-e996132a5b89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791229dilTIAZem hydrochloride 25 MG in 5 mL InjectionPSNfbd7ee32-fabe-06e7-e053-6294a90a63e02
17912295 ML diltiazem hydrochloride 5 MG/ML InjectionSCDfbd7ee32-fabe-06e7-e053-6294a90a63e02
1791229diltiazem hydrochloride 25 MG per 5 ML InjectionSYfbd7ee32-fabe-06e7-e053-6294a90a63e02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-301-057086003010510 VIAL in 1 CARTON (70860-301-05) > 5 mL in 1 VIAL (70860-301-41) 10 vial2019-12-150000-00-00NoNoCurrent
70860-301-107086003011010 VIAL in 1 CARTON (70860-301-10) > 10 mL in 1 VIAL (70860-301-42) 10 vial2019-12-150000-00-00NoNoCurrent
70860-301-257086003012510 VIAL in 1 CARTON (70860-301-25) > 25 mL in 1 VIAL (70860-301-43) 10 vial2019-12-150000-00-00NoNoCurrent