Home NDC 63323-322 Imipenem and Cilastatin
Product NDC 63323-322
11-digit product format 633230322
Labeler code 63323
Product ID 63323-322_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 500; 500 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090577-001 IMIPENEM AND CILASTATIN CILASTATIN SODIUM; IMIPENEM EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 A090577-002 IMIPENEM AND CILASTATIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090577-002 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090577-001 IMIPENEM AND CILASTATIN EQ 250MG BASE/VIAL;250MG/VIAL POWDER / INTRAVENOUS RS 2011-12-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090577-002 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2011-12-21 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Imipenem and Cilastatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IMIPENEM 500 mg/20mL CILASTATIN SODIUM 500 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5428WXZ74M Internal UNII lookup 71OTZ9ZE0A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726204 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-322-01 Imipenem and Cilastatin 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, FOR SOLUTION 20 12 63323-322-25 Imipenem and Cilastatin 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 12 63323-322-41 Imipenem and Cilastatin 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, FOR SOLUTION 20 7 63323-322-94 Imipenem and Cilastatin 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 7 63323-322-21 Imipenem and Cilastatin 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, FOR SOLUTION 20 5 63323-322-93 Imipenem and Cilastatin 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CILASTATIN SODIUM ACTIVE INGREDIENT 5428WXZ74M IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 IMIPENEM ACTIVE INGREDIENT 71OTZ9ZE0A IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 CILASTATIN ACTIVE MOIETY 141A6AMN38 IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 IMIPENEM ANHYDROUS ACTIVE MOIETY Q20IM7HE75 IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 CILASTATIN SODIUM ACTIVE INGREDIENT 5428WXZ74M IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 IMIPENEM ACTIVE INGREDIENT 71OTZ9ZE0A IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 CILASTATIN ACTIVE MOIETY 141A6AMN38 IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 IMIPENEM ANHYDROUS ACTIVE MOIETY Q20IM7HE75 IMIPENEM 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 NDC Dashboard title SPL version Validation Dashboard ZIP 63323-322 IMIPENEM AND CILASTATIN (IMIPENEM AND CILASTATIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 12 Current NDC, Legacy NDC, 2 package rows 20221020_6ab0ca9e-9a79-4cab-9f09-470eda06952e.zip 63323-322 IMIPENEM 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] 7 Current NDC, Legacy NDC, 2 package rows 20221027_0a1dd9b9-ada1-4bff-9dcb-18961254e9e8.zip 63323-322 IMIPENEM 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] 5 Current NDC, Legacy NDC, 2 package rows 20221103_ce771566-c4f2-447e-944a-6b908925c90b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-322-01 63323032201 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 63323-322-21 63323032221 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 63323-322-25 63323032225 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-322-25) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-322-01) 2012-01-03 0000-00-00 No No Current 63323-322-41 63323032241 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 63323-322-93 63323032293 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-322-93) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-322-21) 2012-01-03 0000-00-00 No No Current 63323-322-94 63323032294 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-322-94) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-322-41) 2012-01-03 0000-00-00 No No Current