FDA.reportPublic FDA data

Imipenem and Cilastatin

Product NDC
44567-705
11-digit product format
445670705
Labeler code
44567
Product ID
44567-705_6bfcc077-8c32-4c7e-abaa-f17eb2084231
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipenem and Cilastatin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA207594
Marketing category
ANDA
Marketing start
2021-03-09
Substance
CILASTATIN SODIUM; IMIPENEM ANHYDROUS
Active strength
500; 500 mg/1; mg/1
Pharmacologic classes
Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Imipenem and Cilastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CILASTATIN SODIUM500 mg/1
IMIPENEM ANHYDROUS500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5428WXZ74M, Q20IM7HE75
Rxcui1726214

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
bd5bade3-1b69-46d8-87bd-7d2fbe32b767Product name120200603
bc64ce14-a963-4b05-9b71-737977847052Product name120191008
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-705-10Imipenem and Cilastatin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION18
44567-705-10Imipenem and Cilastatin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-705-10EA - Each44567-705f9cbf7ad-8361-406b-8809-0dff6b5c0f0612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-705IMIPENEM AND CILASTATIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]8Current NDC, Legacy NDC, 2 package rows20250119_46f54df9-5afe-430c-aa19-0d84c2044b0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726214imipenem / cilastatin 500 MG InjectionPSN46f54df9-5afe-430c-aa19-0d84c2044b0b8
1726214cilastatin 500 MG / imipenem 500 MG InjectionSCD46f54df9-5afe-430c-aa19-0d84c2044b0b8
1726214cilastatin (as cilastatin sodium) 500 MG / imipenem 500 MG InjectionSY46f54df9-5afe-430c-aa19-0d84c2044b0b8
1726214imipenem 500 MG / cilastatin 500 MG InjectionSY46f54df9-5afe-430c-aa19-0d84c2044b0b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-705-104456707051010 VIAL in 1 CARTON (44567-705-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2021-03-090000-00-00NoNoCurrent