FDA.reportPublic FDA data

Imipenem and Cilastatin

Product NDC
63323-349
11-digit product format
633230349
Labeler code
63323
Product ID
63323-349_2bb9b6ad-8e8d-4667-b108-b57a8c16318f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipenem and Cilastatin Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA090577
Marketing category
ANDA
Marketing start
2012-01-03
Substance
CILASTATIN SODIUM; IMIPENEM
Active strength
250; 250 mg/20mL; mg/20mL
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 SODIUM250 mg/20mL
IMIPENEM250 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii71OTZ9ZE0A, 5428WXZ74M
Rxcui1726204

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
63323-349-01Imipenem and Cilastatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION2012
63323-349-25Imipenem and Cilastatin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2512
63323-349-41Imipenem and Cilastatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION207
63323-349-94Imipenem and Cilastatin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION257
63323-349-21Imipenem and Cilastatin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION205
63323-349-93Imipenem and Cilastatin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-349-01EA - Each63323-349f50db0b5-d335-4dbf-941f-0f0b369edb4912022-12-07
63323-349-20EA - Each63323-349b9f50790-8b8f-4859-a9a5-09eaa18ef95812012-07-24
63323-349-25EA - Each63323-3490e6995d8-249d-4b78-b0e7-49d68ded7a1412013-02-13
63323-349-93EA - Each63323-3495ef3d27e-c6b0-474c-9e11-3134e31809d312016-07-19
63323-349-94EA - Each63323-349a50513b0-965e-4537-b95f-0d14a7becca912015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CILASTATIN SODIUMACTIVE INGREDIENT5428WXZ74MIMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
IMIPENEMACTIVE INGREDIENT71OTZ9ZE0AIMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
CILASTATINACTIVE MOIETY141A6AMN38IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
IMIPENEM ANHYDROUSACTIVE MOIETYQ20IM7HE75IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
CILASTATIN SODIUMACTIVE INGREDIENT5428WXZ74MIMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
IMIPENEMACTIVE INGREDIENT71OTZ9ZE0AIMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
CILASTATINACTIVE MOIETY141A6AMN38IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
IMIPENEM ANHYDROUSACTIVE MOIETYQ20IM7HE75IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-349IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]12Current NDC, Legacy NDC, 2 package rows20221020_6ab0ca9e-9a79-4cab-9f09-470eda06952e.zip
63323-349IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 2 package rows20221027_0a1dd9b9-ada1-4bff-9dcb-18961254e9e8.zip
63323-349IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20221103_ce771566-c4f2-447e-944a-6b908925c90b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726204imipenem / cilastatin 250 MG InjectionPSN6ab0ca9e-9a79-4cab-9f09-470eda06952e12
1726204cilastatin 250 MG / imipenem 250 MG InjectionSCD6ab0ca9e-9a79-4cab-9f09-470eda06952e12
1726204cilastatin (as cilastatin sodium) 250 MG / imipenem 250 MG InjectionSY6ab0ca9e-9a79-4cab-9f09-470eda06952e12
1726204imipenem 250 MG / cilastatin 250 MG InjectionSY6ab0ca9e-9a79-4cab-9f09-470eda06952e12
1726204imipenem / cilastatin 250 MG InjectionPSN0a1dd9b9-ada1-4bff-9dcb-18961254e9e87
1726204cilastatin 250 MG / imipenem 250 MG InjectionSCD0a1dd9b9-ada1-4bff-9dcb-18961254e9e87
1726204cilastatin (as cilastatin sodium) 250 MG / imipenem 250 MG InjectionSY0a1dd9b9-ada1-4bff-9dcb-18961254e9e87
1726204imipenem 250 MG / cilastatin 250 MG InjectionSY0a1dd9b9-ada1-4bff-9dcb-18961254e9e87
1726204imipenem / cilastatin 250 MG InjectionPSNce771566-c4f2-447e-944a-6b908925c90b5
1726204cilastatin 250 MG / imipenem 250 MG InjectionSCDce771566-c4f2-447e-944a-6b908925c90b5
1726204cilastatin (as cilastatin sodium) 250 MG / imipenem 250 MG InjectionSYce771566-c4f2-447e-944a-6b908925c90b5
1726204imipenem 250 MG / cilastatin 250 MG InjectionSYce771566-c4f2-447e-944a-6b908925c90b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-349-016332303490120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
63323-349-216332303492120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
63323-349-256332303492525 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-25) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-01) 2012-01-030000-00-00NoNoCurrent
63323-349-416332303494120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
63323-349-936332303499325 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-93) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-21) 2012-01-030000-00-00NoNoCurrent
63323-349-946332303499425 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-94) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-41) 2012-01-030000-00-00NoNoCurrent