FDA.reportPublic FDA data

Sildenafil

Product NDC
55150-166
11-digit product format
551500166
Labeler code
55150
Product ID
55150-166_c6f23ad9-ca87-47a3-8d85-dfc334e5a91b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil Citrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA203988
Marketing category
ANDA
Marketing start
2015-04-01
Substance
SILDENAFIL CITRATE
Active strength
10 mg/12.5mL
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE10 mg/12.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui882527

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-166-13Sildenafil1 in 1 CARTONINJECTION, SOLUTION19
55150-166-13Sildenafil12.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12.59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-166-13ML - Milliliter55150-166e85d70a6-6d40-4d1c-b1f5-934daa1af95212015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037SILDENAFIL (SILDENAFIL CITRATE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]2
SILDENAFILACTIVE MOIETY3M7OB98Y7HSILDENAFIL (SILDENAFIL CITRATE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]2
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GSILDENAFIL (SILDENAFIL CITRATE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RSILDENAFIL (SILDENAFIL CITRATE) INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-166SILDENAFIL (SILDENAFIL CITRATE) INJECTION, SOLUTION [EUGIA US LLC]9Current NDC, Legacy NDC, 2 package rows20231227_bb92d686-a81e-4b91-8048-693af0534cb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
882527sildenafil 10 MG in 12.5 ML InjectionPSNbb92d686-a81e-4b91-8048-693af0534cb39
88252712.5 ML sildenafil 0.8 MG/ML InjectionSCDbb92d686-a81e-4b91-8048-693af0534cb39
882527sildenafil (as sildenafil citrate) 10 MG per 12.5 ML InjectionSYbb92d686-a81e-4b91-8048-693af0534cb39
882527sildenafil 10 MG per 12.5 ML InjectionSYbb92d686-a81e-4b91-8048-693af0534cb39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-166-13551500166131 VIAL, SINGLE-DOSE in 1 CARTON (55150-166-13) / 12.5 mL in 1 VIAL, SINGLE-DOSE2015-04-010000-00-00NoNoCurrent