FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
0904-7220
11-digit product format
009047220
Labeler code
0904
Product ID
0904-7220_ef66f466-b51f-4f29-b7a0-f8acc80d3562
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA205231
Marketing category
ANDA
Marketing start
2022-08-09
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
300 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 HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830801, 830837, 830845, 830861

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
0904-7220-61Diltiazem Hydrochloride100 in 1 CARTONCAPSULE, EXTENDED RELEASE1005
0904-7220-61Diltiazem Hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7220-61EA - Each0904-7220d470d730-bd27-45bd-a21c-065d0736f1bc12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7220DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]2Current NDC, Legacy NDC, 2 package rows20240724_e7476adc-a940-4e76-a1dd-c418de493bc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSNe7476adc-a940-4e76-a1dd-c418de493bc05
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNe7476adc-a940-4e76-a1dd-c418de493bc05
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNe7476adc-a940-4e76-a1dd-c418de493bc05
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSNe7476adc-a940-4e76-a1dd-c418de493bc05
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDe7476adc-a940-4e76-a1dd-c418de493bc05
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDe7476adc-a940-4e76-a1dd-c418de493bc05
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDe7476adc-a940-4e76-a1dd-c418de493bc05
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCDe7476adc-a940-4e76-a1dd-c418de493bc05
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSYe7476adc-a940-4e76-a1dd-c418de493bc05
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYe7476adc-a940-4e76-a1dd-c418de493bc05
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYe7476adc-a940-4e76-a1dd-c418de493bc05
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYe7476adc-a940-4e76-a1dd-c418de493bc05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7220-6100904722061100 BLISTER PACK in 1 CARTON (0904-7220-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2022-08-090000-00-00NoNoCurrent