Home NDC 55150-166 Sildenafil
Product NDC 55150-166
11-digit product format 551500166
Labeler code 55150
Product ID 55150-166_c6f23ad9-ca87-47a3-8d85-dfc334e5a91b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sildenafil Citrate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA203988
Marketing category ANDA
Marketing start 2015-04-01
Substance SILDENAFIL CITRATE
Active strength 10 mg/12.5mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203988-001 SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203988-001 AP
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203988-001 SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) SOLUTION / INTRAVENOUS AP 2015-04-01 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sildenafil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILDENAFIL CITRATE 10 mg/12.5mL
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 882527 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 55150-166-13 Sildenafil 1 in 1 CARTON INJECTION, SOLUTION 1 9 55150-166-13 Sildenafil 12.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 12.5 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-166 SILDENAFIL (SILDENAFIL CITRATE) INJECTION, SOLUTION [EUGIA US LLC] 9 Current NDC, Legacy NDC, 2 package rows 20231227_bb92d686-a81e-4b91-8048-693af0534cb3.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 Marketing start Marketing end Sample Exclude flag Status 55150-166-13 55150016613 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-166-13) / 12.5 mL in 1 VIAL, SINGLE-DOSE 2015-04-01 0000-00-00 No No Current