Home NDC 14335-133 Sodium Nitroprusside
Product NDC 14335-133
11-digit product format 143350133
Labeler code 14335
Product ID 14335-133_e826d769-c243-f0ac-e053-2995a90afcff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Nitroprusside
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hainan Poly Pharm. Co., Ltd.
Application ANDA215846
Marketing category ANDA
Marketing start 2022-12-31
Substance SODIUM NITROPRUSSIDE
Active strength .2 mg/mL
Pharmacologic classes Vasodilation [PE], Vasodilator [EPC]
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215846-001 SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 A215846-002 SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 A215846-003 SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 81 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 2026-02-19 14:30 UTC 2026-02 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215846-002 SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215846-003 SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215846-001 SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) SOLUTION / INTRAVENOUS 2022-08-26 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sodium Nitroprusside
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM NITROPRUSSIDE .2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EAO03PE1TC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1876368 Internal RxNorm lookup 1999185 Internal RxNorm lookup 2052423 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 14335-133-01 Sodium Nitroprusside 1 in 1 CARTON INJECTION, SOLUTION 1 1 14335-133-01 Sodium Nitroprusside 100 mL in 1 VIAL INJECTION, SOLUTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14335-133 SODIUM NITROPRUSSIDE INJECTION, SOLUTION [HAINAN POLY PHARM. CO., LTD.] 1 Current NDC, Legacy NDC, 2 package rows 20221231_72a9b7df-3a2f-4c16-93a9-b645bc0e8143.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 · 2 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 14335-133-01 14335013301 1 VIAL in 1 CARTON (14335-133-01) / 100 mL in 1 VIAL 1 vial 2022-12-31 0000-00-00 No No Current