Sildenafil

Product NDC
31722-136
11-digit product format
317220136
Labeler code
31722
Product ID
31722-136_1389f9d0-c617-8381-e063-6394a90a7a76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil Powder,
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA213014
Marketing category
ANDA
Marketing start
2021-05-11
Substance
SILDENAFIL CITRATE
Active strength
10 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui1307427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-136-31Sildenafil1 in 1 CARTONFOR SUSPENSION13
31722-136-31Sildenafil112 mL in 1 BOTTLE, GLASSFOR SUSPENSION1123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-136-31ML - Milliliter31722-1365130c3a6-96c4-4b4f-a5f8-ad275df0632812021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-136SILDENAFIL (SILDENAFIL POWDER,) FOR SUSPENSION [CAMBER PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20240315_598f2b9c-cfb9-4f26-8508-83ca5055c305.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307427sildenafil 10 MG in 1 mL Oral SuspensionPSN598f2b9c-cfb9-4f26-8508-83ca5055c3053
1307427sildenafil 10 MG/ML Oral SuspensionSCD598f2b9c-cfb9-4f26-8508-83ca5055c3053
1307427sildenafil (as sildenafil citrate) 10 MG/ML Powder for Oral SuspensionSY598f2b9c-cfb9-4f26-8508-83ca5055c3053
1307427sildenafil 10 MG per 1 ML Oral SuspensionSY598f2b9c-cfb9-4f26-8508-83ca5055c3053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-136-31317220136311 BOTTLE, GLASS in 1 CARTON (31722-136-31) / 112 mL in 1 BOTTLE, GLASS2021-05-110000-00-00NoNoCurrent