Home NDC 44567-705 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 IMIPENEM ANHYDROUS; CILASTATIN SODIUM
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207594-001 IMIPENEM AND CILASTATIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207594-001 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.
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 2026-09-14 22:38:34 2026-08 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207594-001 IMIPENEM AND CILASTATIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP 2019-12-12 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 ANHYDROUS 500 mg/1 CILASTATIN SODIUM 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q20IM7HE75 Internal UNII lookup 5428WXZ74M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726214 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 44567-705-10 Imipenem and Cilastatin 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 8 44567-705-10 Imipenem and Cilastatin 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44567-705 IMIPENEM AND CILASTATIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20250119_46f54df9-5afe-430c-aa19-0d84c2044b0b.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 · 1 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 44567-705-10 44567070510 10 VIAL in 1 CARTON (44567-705-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 10 vial 2021-03-09 0000-00-00 No No Current