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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213014-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213014-001AB

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
2026-08-18 06:07:402026-07A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-114b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213014-001SILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALAB2021-05-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213014-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213014-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213014-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213014-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213014-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213014-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213014-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213014-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213014-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213014-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213014-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213014-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213014-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213014-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213014-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213014-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213014-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213014-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213014-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213014-001AB1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213014-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213014-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213014-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213014-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213014-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213014-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213014-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213014-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A213014-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213014-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213014-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213014-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213014-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213014-001AB1a50c72e98297…

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 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
1307427Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
598f2b9c-cfb9-4f26-8508-83ca5055c305Available 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
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SildenafilSILDENAFIL POWDER,Camber Pharmaceuticals, Inc.598f2b9c-cfb9-4f26-8508-83ca5055c3052024-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213014
application number: ANDA213014
ndc (product): 31722-136

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