FDA.reportPublic FDA data

Sildenafil

Product NDC
68001-597
Requested package NDC
68001-597-05
11-digit product format
680010597
Labeler code
68001
Product ID
68001-597_28da809a-99b6-e220-e063-6294a90ac8ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA203814
Marketing category
ANDA
Marketing start
2023-06-12
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203814-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2013-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A203814-001AB

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 22:54:322026-06A203814-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2013-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203814-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SildenafilSILDENAFILAmerican Health Packagingf7fbfc3b-807e-4375-a6eb-8db0eaf40c9c2025-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203814
application number: ANDA203814
SildenafilSILDENAFILMacleods Pharmaceuticals Limited61a0ebd9-8dc9-4bcc-b07b-f3d6398ea96e2025-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203814
application number: ANDA203814
SildenafilSILDENAFILBluePoint Laboratoriesbe6d1015-306d-44fb-8d4d-01724b8d95902024-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203814
application number: ANDA203814
ndc (package): 68001-597-05
ndc (product): 68001-597
ndc11 (package): 68001059705
SildenafilSILDENAFILNuCare Pharmaceuticals, Inc.46dff4c0-9a6c-20f9-e054-00144ff8d46c2024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203814
application number: ANDA203814
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.97ccea8a-6d5a-129f-e053-2995a90aa8372024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203814
application number: ANDA203814
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.72900ed9-dbab-3f7b-e053-2a91aa0a0d242024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203814
application number: ANDA203814
SildenafilSILDENAFILBryant Ranch Prepack7c01fd56-5dd6-4728-9f2a-e0f5db8102692023-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203814
application number: ANDA203814
SildenafilSILDENAFILMacleods Pharmaceuticals Limitedd2892f4b-f5ba-42f5-b373-310241f4efa72023-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203814
application number: ANDA203814
SildenafilSILDENAFILAsclemed USA, Inc.06571775-b651-4e23-a35b-88392aae7e132022-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203814
application number: ANDA203814
SildenafilSILDENAFILBryant Ranch Prepack85767ed7-932b-4e2b-8bba-b59bb45ce1162020-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203814
application number: ANDA203814
SildenafilSILDENAFILProficient Rx LP2538995d-2df6-4c87-978a-5513c670b60f2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203814
application number: ANDA203814

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BW9B0ZE037Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
577033Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
be6d1015-306d-44fb-8d4d-01724b8d9590Available on FDA.report

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
68001-597-05Sildenafil90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-597-05EA - Each68001-5979fd2b14c-3225-4edc-a6fc-1b42ff230f4112023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-597SILDENAFIL TABLET, FILM COATED [BLUEPOINT LABORATORIES]10Current NDC, 1 package rows20241213_be6d1015-306d-44fb-8d4d-01724b8d9590.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNbe6d1015-306d-44fb-8d4d-01724b8d959010
577033sildenafil 20 MG Oral TabletSCDbe6d1015-306d-44fb-8d4d-01724b8d959010
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYbe6d1015-306d-44fb-8d4d-01724b8d959010
577033sildenafil citrate 20 MG Oral TabletPSNf7fbfc3b-807e-4375-a6eb-8db0eaf40c9c7
577033sildenafil 20 MG Oral TabletSCDf7fbfc3b-807e-4375-a6eb-8db0eaf40c9c7
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf7fbfc3b-807e-4375-a6eb-8db0eaf40c9c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-597-056800105970590 TABLET, FILM COATED in 1 BOTTLE (68001-597-05) 2023-06-12NoNoCurrent