FDA.reportPublic FDA data

NDC 0409-6695-12 - Amidate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0409-6695
Requested NDC
0409-6695-12
Package NDCs from labels
0409-6695-11, 0409-6695-01, 0409-6695-12, 0409-6695-02
Manufacturer
Hospira, Inc.
Effective date
2026-05-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMIDATE™ (etomidate) injection, USP 2 mg/mLHospira, Inc.2026-05-20HUMAN PRESCRIPTION DRUG LABEL
Amidate™ (etomidate) injection, USP 2 mg/mL For intravenous use EN-6082Henry Schein, Inc.2025-10-27HUMAN PRESCRIPTION DRUG LABEL
AMIDATE(TM) ETOMIDATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2023-10-10HUMAN PRESCRIPTION DRUG LABEL
Amidate - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-06HUMAN PRESCRIPTION DRUG LABEL
AMIDATE(TM) ETOMIDATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2020-02-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-6695-01Amidate10 in 1 TRAYINJECTION, SOLUTION1027
0409-6695-02Amidate10 in 1 TRAYINJECTION, SOLUTION1027
0409-6695-11Amidate10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1027
0409-6695-12Amidate20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-6695AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HOSPIRA, INC.]26Current NDC, Legacy NDC, 4 package rows20241210_b7ed5bf8-ba75-44dc-8f81-96b4ad5766be.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6695-01ML - Milliliter0409-66958812c4ff-eeea-4683-be0e-6d829940fb0b12012-07-24
0409-6695-02ML - Milliliter0409-6695bfb4cb7f-6675-4a2e-a30c-7906e046428912012-07-24
0409-6695-09ML - Milliliter0409-6695da70d249-edc4-421b-9da4-c5f76368c16212016-03-04
0409-6695-10ML - Milliliter0409-66952a2aa193-897b-4702-b2af-d43ebe29845c12016-03-04
0409-6695-11ML - Milliliter0409-669593955484-c7cc-49aa-8061-b2aef2cfbaf612018-02-20
0409-6695-12ML - Milliliter0409-66954fb64ce9-309d-4b65-b411-efd6bd72fe9412018-02-20
0409-6695-19ML - Milliliter0409-66953a20abc0-8317-4f04-b84d-60b14f7ae53812016-03-04
0409-6695-20ML - Milliliter0409-6695b5c530c1-f98c-43d9-b239-19c967b217e012016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETOMIDATEACTIVE INGREDIENTZ22628B598AMIDATE (ETOMIDATE) INJECTION, SOLUTION AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
ETOMIDATEACTIVE MOIETYZ22628B598AMIDATE (ETOMIDATE) INJECTION, SOLUTION AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMIDATE (ETOMIDATE) INJECTION, SOLUTION AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RAMIDATE (ETOMIDATE) INJECTION, SOLUTION AMIDATE (ETOMIDATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EtomidateACTIVE INGREDIENTZ22628B598AMIDATE (ETOMIDATE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]4
EtomidateACTIVE MOIETYZ22628B598AMIDATE (ETOMIDATE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]4

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 2 of 14 · 264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AmidateETOMIDATEHospira, Inc.b7ed5bf8-ba75-44dc-8f81-96b4ad5766be2026-05-20Warnings, Adverse reactionsExact identifier
application number: NDA018227
ndc (package): 0409-6695-01
ndc (package): 0409-6695-11
ndc (package): 0409-6695-12
ndc (package): 0409-6695-02
ndc (product): 0409-6695
ndc11 (package): 00409669512
rxcui: 1654006
rxcui: 1654008
rxcui: 1654009
rxcui: 1654011
spl id: 3f83ed21-1b60-486c-8c70-1d5aa7553404
spl set id: b7ed5bf8-ba75-44dc-8f81-96b4ad5766be
unii: Z22628B598
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.