FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
0641-6013
11-digit product format
006416013
Labeler code
0641
Product ID
0641-6013_fb823cdb-b2d1-4821-ba0e-d1af2cee72c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078538
Marketing category
ANDA
Marketing start
2008-12-17
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
5 mg/mL
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui1791229, 1791232, 1791233

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6013-01Diltiazem Hydrochloride5 mL in 1 VIALINJECTION55
0641-6013-10Diltiazem Hydrochloride10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6013-01ML - Milliliter0641-6013bd46813c-ccbc-429a-8129-b69249207df812012-07-24
0641-6013-10ML - Milliliter0641-60135a1e1049-8d91-4e79-a05b-758a1fbe9a1a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
DILTIAZEMACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RDILTIAZEM HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6013DILTIAZEM HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20240410_453b73bd-c52d-4d72-a0b3-47588e723e0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791233dilTIAZem hydrochloride 125 MG in 25 mL InjectionPSN453b73bd-c52d-4d72-a0b3-47588e723e0b5
1791229dilTIAZem hydrochloride 25 MG in 5 mL InjectionPSN453b73bd-c52d-4d72-a0b3-47588e723e0b5
1791229dilTIAZem hydrochloride 25 MG in 5 mL InjectionPSN7d8e8b1e-f67b-57d2-e053-2991aa0a8d125
1791232dilTIAZem hydrochloride 50 MG in 10 mL InjectionPSN453b73bd-c52d-4d72-a0b3-47588e723e0b5
179123210 ML diltiazem hydrochloride 5 MG/ML InjectionSCD453b73bd-c52d-4d72-a0b3-47588e723e0b5
179123325 ML diltiazem hydrochloride 5 MG/ML InjectionSCD453b73bd-c52d-4d72-a0b3-47588e723e0b5
17912295 ML diltiazem hydrochloride 5 MG/ML InjectionSCD453b73bd-c52d-4d72-a0b3-47588e723e0b5
17912295 ML diltiazem hydrochloride 5 MG/ML InjectionSCD7d8e8b1e-f67b-57d2-e053-2991aa0a8d125
1791233diltiazem hydrochloride 125 MG per 25 ML InjectionSY453b73bd-c52d-4d72-a0b3-47588e723e0b5
1791229diltiazem hydrochloride 25 MG per 5 ML InjectionSY453b73bd-c52d-4d72-a0b3-47588e723e0b5
1791229diltiazem hydrochloride 25 MG per 5 ML InjectionSY7d8e8b1e-f67b-57d2-e053-2991aa0a8d125
1791232diltiazem hydrochloride 50 MG per 10 ML InjectionSY453b73bd-c52d-4d72-a0b3-47588e723e0b5
1791229dilTIAZem hydrochloride 25 MG in 5 mL InjectionPSN9f69371d-3ede-285d-e053-2a95a90a6e422
17912295 ML diltiazem hydrochloride 5 MG/ML InjectionSCD9f69371d-3ede-285d-e053-2a95a90a6e422
1791229diltiazem hydrochloride 25 MG per 5 ML InjectionSY9f69371d-3ede-285d-e053-2a95a90a6e422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6013-01006416013015 mL in 1 VIAL5 mlHistorical
0641-6013-100064160131010 VIAL in 1 CARTON (0641-6013-10) / 5 mL in 1 VIAL (0641-6013-01) 10 vial2008-12-170000-00-00NoNoCurrent