Sodium Nitroprusside

Product NDC
75907-290
11-digit product format
759070290
Labeler code
75907
Product ID
75907-290_b246076f-49e6-6a0d-e065-9b3f853adb2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Nitroprusside
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Dr.Reddy's Laboratories Inc.,
Application
ANDA210114
Marketing category
ANDA
Marketing start
2025-12-01
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210114-001SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A210114-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-103f01610625f2…
2019-09-15 20:21 UTC2019-09A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210114-001SODIUM NITROPRUSSIDE25MG/MLINJECTABLE / INJECTIONAP2019-04-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210114-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210114-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210114-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210114-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210114-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210114-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210114-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210114-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210114-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210114-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210114-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210114-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210114-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210114-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210114-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210114-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210114-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210114-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210114-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210114-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210114-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A210114-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210114-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210114-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210114-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A210114-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A210114-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210114-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210114-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210114-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210114-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210114-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210114-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210114-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210114-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210114-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210114-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210114-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210114-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210114-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Nitroprusside
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM NITROPRUSSIDE50 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EAO03PE1TCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240793Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3b83d0e-b8f7-5e90-c363-1edfcd27a33dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baa2d9bb-fc02-4e7a-afa2-38f3bd0d9f47Product name220230501
374f859f-b175-4ec0-a0a3-35bda0517e25Product name920200522

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-290-11Sodium Nitroprusside2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION21
75907-290-11Sodium Nitroprusside1 in 1 CARTONINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-290-11ML - Milliliter75907-2903c72d7c0-248b-4b9a-befa-9198036d1ab112025-12-16

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium NitroprussideSODIUM NITROPRUSSIDEDr.Reddy's Laboratories Inc.,a3b83d0e-b8f7-5e90-c363-1edfcd27a33d2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210114
application number: ANDA210114
ndc (product): 75907-290
Sodium NitroprussideSODIUM NITROPRUSSIDEDr.Reddy's Laboratories Inc.,5a689f89-3cbd-f9fa-13cc-26063feb9c832024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210114
application number: ANDA210114

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240793sodium nitroprusside 50 MG in 2 ML InjectionPSNa3b83d0e-b8f7-5e90-c363-1edfcd27a33d1
2407932 ML sodium nitroprusside 25 MG/ML InjectionSCDa3b83d0e-b8f7-5e90-c363-1edfcd27a33d1
240793sodium nitroprusside 25 MG/ML per 2 ML InjectionSYa3b83d0e-b8f7-5e90-c363-1edfcd27a33d1
240793sodium nitroprusside 50 MG per 2 ML InjectionSYa3b83d0e-b8f7-5e90-c363-1edfcd27a33d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
75907-290-11759070290111 VIAL, SINGLE-DOSE in 1 CARTON (75907-290-11) / 2 mL in 1 VIAL, SINGLE-DOSE2025-12-01NoNoCurrent