FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
50090-5466
11-digit product format
500905466
Labeler code
50090
Product ID
50090-5466_ca8bbf8c-0492-4e1e-ba94-38cba20eb8c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205231
Marketing category
ANDA
Marketing start
2018-10-01
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diltiazem Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830845

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
50090-5466-0Diltiazem Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3012
50090-5466-1Diltiazem Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5466-0EA - Each50090-546607023009-8744-4e87-8520-dd28cda3178612022-11-07
50090-5466-1EA - Each50090-546615b1480d-87d8-40fc-acd4-f4788df7828f12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5466DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20240731_465dbab3-f201-4441-8f55-92a843b5134f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN465dbab3-f201-4441-8f55-92a843b5134f12
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD465dbab3-f201-4441-8f55-92a843b5134f12
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY465dbab3-f201-4441-8f55-92a843b5134f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5466-05009054660030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5466-0) 2021-02-080000-00-00NoNoCurrent
50090-5466-15009054660190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5466-1) 2021-02-080000-00-00NoNoCurrent