Home NDC 68180-283 SILDENAFIL
Product NDC 68180-283
11-digit product format 681800283
Labeler code 68180
Product ID 68180-283_18727593-f734-4bd5-88eb-625779d35660
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sildenafil
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA211638
Marketing category ANDA
Marketing start 2022-09-28
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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211638-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL 2022-03-23
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL 2022-03-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL 2022-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL 2022-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL 2022-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL AB 2022-03-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211638-001 SILDENAFIL CITRATE EQ 10MG BASE/ML FOR SUSPENSION / ORAL 2022-03-23 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base SILDENAFIL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILDENAFIL CITRATE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BW9B0ZE037 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1307427 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-283-01 SILDENAFIL 112 mL in 1 BOTTLE POWDER, FOR SUSPENSION 112 10 68180-283-01 SILDENAFIL 1 in 1 CARTON POWDER, FOR SUSPENSION 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-283 SILDENAFIL POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20231208_407ee7fc-0022-4fac-9fa6-4285d774fdb3.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-283-01 68180028301 1 BOTTLE in 1 CARTON (68180-283-01) / 112 mL in 1 BOTTLE 1 bottle 2022-09-28 0000-00-00 No No Current