Home NDC 65145-101-01 Sodium Nitroprusside
Product NDC 65145-101
Requested package NDC 65145-101-01
11-digit product format 651450101
Labeler code 65145
Product ID 65145-101_eb59b468-0778-4910-820c-36ca56b935d5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Nitroprusside
Dosage form INJECTION
Route INTRAVENOUS
Labeler Caplin Steriles Limited
Application ANDA211016
Marketing category ANDA
Marketing start 2025-10-29
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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 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 A211016-001 SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211016-001 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.
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 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211016-001 SODIUM NITROPRUSSIDE 25MG/ML INJECTABLE / INJECTION AP 2019-11-29 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 65145-101-01 Sodium Nitroprusside 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 4 65145-101-01 Sodium Nitroprusside 1 in 1 CARTON INJECTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65145-101 SODIUM NITROPRUSSIDE INJECTION [CAPLIN STERILES LIMITED] 3 Current NDC, Legacy NDC, 2 package rows 20191210_a8c5d04b-c6cb-46e6-b90c-e858a0a52406.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 65145-101-01 65145010101 1 VIAL, SINGLE-DOSE in 1 CARTON (65145-101-01) / 2 mL in 1 VIAL, SINGLE-DOSE 2025-10-29 0000-00-00 No No Current