FDA.reportPublic FDA data

Imipenem and Cilastatin

Product NDC
0409-3508
11-digit product format
004093508
Labeler code
0409
Product ID
0409-3508_ad96cecb-40e9-4197-809d-0788fe641543
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipenem and Cilastatin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA090825
Marketing category
ANDA
Marketing start
2011-11-16
Marketing end
0000-00-00
Substance
IMIPENEM; CILASTATIN SODIUM
Active strength
250 mg/100mL; mg/100mL
Pharmacologic classes
Carbapenems [CS],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-3508DDiscontinued by firm2026-07-31
excluded productproduct0409-3508DDiscontinued by firm2026-07-31
excluded packagepackage0409-35080409-3508-01DDiscontinued by firm2026-07-31
excluded packagepackage0409-35080409-3508-10DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090825-001IMIPENEM AND CILASTATINCILASTATIN SODIUM; IMIPENEMEQ 250MG BASE/VIAL;250MG/VIALPOWDER / INTRAVENOUS2011-11-16
A090825-002IMIPENEM AND CILASTATINCILASTATIN SODIUM; IMIPENEMEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUS2011-11-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090825-001IMIPENEM AND CILASTATINEQ 250MG BASE/VIAL;250MG/VIALPOWDER / INTRAVENOUS2011-11-16a50c72e98297…
2026-08-01 22:54:322026-06A090825-002IMIPENEM AND CILASTATINEQ 500MG BASE/VIAL;500MG/VIALPOWDER / INTRAVENOUS2011-11-16a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3508-01EA - Each0409-35080f79e26e-809c-4a7a-9c7b-ea208692d95f12012-07-24
0409-3508-10EA - Each0409-350825627020-cf04-4d43-b515-8419879bdded12013-02-13
0409-3508-21EA - Each0409-3508d186a073-72e5-4f21-a1af-e548e7c3625d12016-04-04