FDA.reportPublic FDA data

Sterile Water

Product NDC
63323-185
11-digit product format
633230185
Labeler code
63323
Product ID
63323-185_42c6c812-706a-425b-b8cb-931006e40484
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
WATER
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA088400
Marketing category
ANDA
Marketing start
2000-09-05
Substance
WATER
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sterile Water
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER1 mL/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii059QF0KO0R

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83f7a8cc-8fbf-4478-9a44-b6214b840d9aProduct name220250812
e86469f1-0431-b4e2-fe09-0dbe527624d7Product name220250804
1e832aa0-608b-424f-9ced-615cef2ff5c5Product name120200220
6ee0758f-9a1a-41ee-90c4-3adce06b52b4Product name120191120
e4138432-bbdb-43bd-8e68-9964f0048734Product name120190228
750a4794-c0e1-4ac9-9af5-006ecec3bb04Product name120150608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-185-04Sterile Water5 mL in 1 VIAL, SINGLE-DOSEINJECTION58
63323-185-05Sterile Water25 in 1 TRAYINJECTION258
63323-185-07Sterile Water10 mL in 1 VIALINJECTION108
63323-185-08Sterile Water20 mL in 1 VIALINJECTION208
63323-185-09Sterile Water50 mL in 1 VIALINJECTION508
63323-185-10Sterile Water25 in 1 TRAYINJECTION258
63323-185-20Sterile Water25 in 1 TRAYINJECTION258
63323-185-50Sterile Water25 in 1 TRAYINJECTION258
63323-185-03Glucagon1 mL in 1 VIAL, SINGLE-DOSEINJECTION1 mL1 mL in 1mL7
63323-185-03Glucagon1 mL in 1 VIAL, SINGLE-DOSEINJECTION1 mL1 mL in 1mL6
63323-185-82Glucagon1 mL in 1 SYRINGE, GLASSINJECTION1 mL1 mL in 1mL5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-185-00ML - Milliliter63323-185609372aa-98b8-4f00-9e6a-abb1487abd1412014-12-01
63323-185-04ML - Milliliter63323-18585267d45-614b-48e8-8d11-2af1614a79a612022-11-07
63323-185-05ML - Milliliter63323-185ed5e269f-f785-44e0-a2eb-21663d2348a012014-12-01
63323-185-07ML - Milliliter63323-185b87e5d9c-faa0-424c-b288-6f564ce4f34b12022-02-07
63323-185-08ML - Milliliter63323-185d5906835-0663-4376-979f-66773354b84312022-02-07
63323-185-09ML - Milliliter63323-185630fe398-09fc-473b-9503-4b65d83609e712022-02-07
63323-185-10ML - Milliliter63323-1857567cc84-d09c-49ee-9540-caf963a8be9f12014-11-05
63323-185-20ML - Milliliter63323-18583df970a-0a1b-4537-9b6f-7128f352dd5112014-11-05
63323-185-50ML - Milliliter63323-18594d5c391-36bd-4b25-9b72-91f4c5d9ed4512014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLUCAGON HYDROCHLORIDEACTIVE INGREDIENT1H87NVF4DBGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
GLUCAGON HYDROCHLORIDEACTIVE INGREDIENT1H87NVF4DBGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
Indocyanine greenACTIVE INGREDIENTIX6J1063HVINDOCYANINE GREEN KIT INDOCYANINE GREEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADAQ TECHNOLOGIES INC.]1
GLUCAGONACTIVE MOIETY76LA80IG2GGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
GLUCAGONACTIVE MOIETY76LA80IG2GGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
Indocyanine greenACTIVE MOIETYIX6J1063HVINDOCYANINE GREEN KIT INDOCYANINE GREEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADAQ TECHNOLOGIES INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
sodium iodideINACTIVE INGREDIENTF5WR8N145CINDOCYANINE GREEN KIT INDOCYANINE GREEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADAQ TECHNOLOGIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-185STERILE WATER (WATER) INJECTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 8 package rows20220624_e71c6c83-d518-496c-b2ab-efd5987e4783.zip
63323-185GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GLUCAGON KIT [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC20211118_e4be1c0e-0fe6-45a0-9229-5cde98434b84.zip
63323-185GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GLUCAGON KIT [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC20220420_8c8acad6-44cc-43aa-966b-027e053be8f5.zip
63323-185GLUCAGON (GLUCAGON) KIT [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC20250402_c5c431b4-5618-4ff4-954e-4c0fbfed67b6.zip
63323-185INDOCYANINE GREEN KIT INDOCYANINE GREEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADAQ TECHNOLOGIES INC.]1Current NDC, Legacy NDC20111201_c1031b17-b6e3-4153-869f-30d9c7e66bc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310497glucagon (rDNA) 1 MG InjectionPSNe4be1c0e-0fe6-45a0-9229-5cde98434b847
310497glucagon (rDNA) 1 MG InjectionSCDe4be1c0e-0fe6-45a0-9229-5cde98434b847
310497glucagon (rDNA) 1 MG InjectionPSN8c8acad6-44cc-43aa-966b-027e053be8f56
310497glucagon (rDNA) 1 MG InjectionSCD8c8acad6-44cc-43aa-966b-027e053be8f56
310497glucagon (rDNA) 1 MG InjectionPSNc5c431b4-5618-4ff4-954e-4c0fbfed67b65
310497glucagon (rDNA) 1 MG InjectionSCDc5c431b4-5618-4ff4-954e-4c0fbfed67b65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-185-006332301850025 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-00) > 100 mL in 1 VIAL, SINGLE-DOSE2000-09-050000-00-00NoNoCurrent
63323-185-03633230185031 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-185-04633230185045 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
63323-185-056332301850525 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04) 2022-04-300000-00-00NoNoCurrent
63323-185-076332301850710 mL in 1 VIAL10 mlHistorical
63323-185-086332301850820 mL in 1 VIAL20 mlHistorical
63323-185-096332301850950 mL in 1 VIAL50 mlHistorical
63323-185-106332301851025 VIAL in 1 TRAY (63323-185-10) / 10 mL in 1 VIAL (63323-185-07) 25 vial2000-09-050000-00-00NoNoCurrent
63323-185-206332301852025 VIAL in 1 TRAY (63323-185-20) / 20 mL in 1 VIAL (63323-185-08) 25 vial2000-09-050000-00-00NoNoCurrent
63323-185-506332301855025 VIAL in 1 TRAY (63323-185-50) / 50 mL in 1 VIAL (63323-185-09) 25 vial2000-09-050000-00-00NoNoCurrent
63323-185-82633230185821 mL in 1 SYRINGE, GLASS1 mlHistorical