FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
60290-002
Requested package NDC
60290-002-02
11-digit product format
602900002
Labeler code
60290
Product ID
60290-002_51b76a30-43fd-eaa4-e063-6394a90a286d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Umedica Laboratories USA Inc.
Application
ANDA209302
Marketing category
ANDA
Marketing start
2026-02-15
Substance
SILDENAFIL CITRATE
Active strength
50 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209302-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-08-25
A209302-002SILDENAFIL CITRATESILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-08-25
A209302-003SILDENAFIL CITRATESILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2021-06-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A209302-001AB
A209302-002AB
A209302-003AB

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 22:54:322026-06A209302-001SILDENAFIL CITRATEEQ 50MG BASETABLET / ORALAB2020-08-25a50c72e98297…
2026-08-01 22:54:322026-06A209302-002SILDENAFIL CITRATEEQ 100MG BASETABLET / ORALAB2020-08-25a50c72e98297…
2026-08-01 22:54:322026-06A209302-003SILDENAFIL CITRATEEQ 25MG BASETABLET / ORALAB2021-06-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209302-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209302-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A209302-003AB1a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SILDENAFIL CITRATESILDENAFIL CITRATEPD-Rx Pharmaceuticals, Inc.00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEPD-Rx Pharmaceuticals, Inc.f1122baa-8dee-43fc-bd3d-501a55b696b32026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEUmedica Laboratories USA Inc.90477a51-63ba-43f4-a74b-4659a946093c2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
ndc (package): 60290-002-02
ndc (product): 60290-002
ndc11 (package): 60290000202
SILDENAFIL CITRATESILDENAFIL CITRATENIVAGEN PHARMACEUTICALS, INC.5ac95dd0-57e4-495c-bf8d-b2e5bbe33e202026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATENorthstar Rx LLC8127ff38-2761-49ec-8ce7-7f971f521cfb2026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP8780c159-8b61-402b-afbe-64f5c85d38862025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP30ce6e7f-716e-4a68-a4fb-2bb2d34ed0522025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP1add0cab-8873-4cd1-ab53-e05c4ac458b12025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEPD-Rx Pharmaceuticals, Inc.dc4430cc-8238-4d6d-99ff-bbb9d0b51bd12025-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEAdvanced Rx of Tennessee, LLC30cb7d6a-ce40-c794-e063-6294a90a68612025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEPreferred Pharmaceuticals Inc.5846bff2-6a93-46a7-a547-04459c5908142025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEA-S Medication Solutions6d79946b-72a9-4d1b-a84b-9d1a679a82e22024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP59b623bc-fbdd-4f32-8327-0d600763f4292022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209302
application number: ANDA209302

Additional Listing Data#

Finished product
Yes
Brand name base
SILDENAFIL CITRATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE50 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312950Internal RxNorm lookup
314228Internal RxNorm lookup
314229Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
90477a51-63ba-43f4-a74b-4659a946093cAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60290-002-012019-11-27C16284748780-19855e2a2-3f7e-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
60290-002-022019-11-27C16284748780-19855e2a2-3f7e-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
60290-002-032019-11-27C16284748780-19855e2a2-3f7e-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60290-002-01SILDENAFIL CITRATE30 in 1 BOTTLETABLET, FILM COATED304
60290-002-02SILDENAFIL CITRATE100 in 1 BOTTLETABLET, FILM COATED1004
60290-002-03SILDENAFIL CITRATE1000 in 1 BOTTLETABLET, FILM COATED10004
60290-002-04SILDENAFIL CITRATE500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN90477a51-63ba-43f4-a74b-4659a946093c4
314228sildenafil citrate 25 MG Oral TabletPSN90477a51-63ba-43f4-a74b-4659a946093c4
312950sildenafil citrate 50 MG Oral TabletPSN90477a51-63ba-43f4-a74b-4659a946093c4
314229sildenafil 100 MG Oral TabletSCD90477a51-63ba-43f4-a74b-4659a946093c4
314228sildenafil 25 MG Oral TabletSCD90477a51-63ba-43f4-a74b-4659a946093c4
312950sildenafil 50 MG Oral TabletSCD90477a51-63ba-43f4-a74b-4659a946093c4
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY90477a51-63ba-43f4-a74b-4659a946093c4
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY90477a51-63ba-43f4-a74b-4659a946093c4
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY90477a51-63ba-43f4-a74b-4659a946093c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60290-002-0260290000202100 TABLET, FILM COATED in 1 BOTTLE (60290-002-02) 2026-02-15NoNoCurrent