Home NDC 42571-265 SODIUM NITROPRUSSIDE
Product NDC 42571-265
11-digit product format 425710265
Labeler code 42571
Product ID 42571-265_2e500795-07a7-f0f7-e063-6294a90a4e8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM NITROPRUSSIDE
Dosage form INJECTION
Route INTRAVENOUS
Labeler Micro Labs Limited
Application ANDA209352
Marketing category ANDA
Marketing start 2017-12-30
Substance SODIUM NITROPRUSSIDE
Active strength 50 mg/2mL
Pharmacologic classes Vasodilation [PE], Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42571-265-75 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42571-265-75 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42571-265-75 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A209352-001 SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209352-001 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 · 41 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 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP RS 2017-12-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209352-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2017-12-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base SODIUM NITROPRUSSIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM NITROPRUSSIDE 50 mg/2mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240793 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42571-265-75 SODIUM NITROPRUSSIDE 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 6 42571-265-75 SODIUM NITROPRUSSIDE 1 in 1 CARTON INJECTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-265 SODIUM NITROPRUSSIDE (SODIUM NITROPRUSSIDE) INJECTION [MICRO LABS LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20250221_5a599880-c133-44ef-a9f2-bd1b681563be.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 Marketing start Marketing end Sample Exclude flag Status 42571-265-75 42571026575 1 VIAL, SINGLE-DOSE in 1 CARTON (42571-265-75) / 2 mL in 1 VIAL, SINGLE-DOSE 2017-12-30 0000-00-00 No No Current