Rocuronium bromide

Product NDC
71479-004
11-digit product format
714790004
Labeler code
71479
Product ID
71479-004_d59a71ae-bd7e-43aa-ae77-fd956573db7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rocuronium bromide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sanovel Ilac San. Ve Tic.A.S.
Application
ANDA210437
Marketing category
ANDA
Marketing start
2019-12-31
Marketing end
0000-00-00
Substance
ROCURONIUM BROMIDE
Active strength
100 mg/10mL
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71479-004IInactivated by FDA2026-08-11
excluded packagepackage71479-00471479-004-10IInactivated by FDA2026-08-11

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 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71479-004-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71479-004-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71479-004-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71479-004-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71479-004-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71479-004-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71479-004-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71479-004-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71479-004-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71479-004-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71479-004-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71479-004-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71479-004-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71479-004-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71479-004-101332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage71479-004-10fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage71479-004-1086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage71479-004-10bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage71479-004-108dfbde2a14a4…c9ff85d89658…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210437-001ROCURONIUM BROMIDEROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13
A210437-002ROCURONIUM BROMIDEROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A210437-001AP
A210437-002AP

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 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210437-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A210437-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2019-08-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210437-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210437-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210437-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210437-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210437-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210437-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210437-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210437-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210437-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210437-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210437-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210437-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210437-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210437-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210437-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210437-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210437-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210437-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210437-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210437-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210437-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210437-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210437-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210437-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210437-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210437-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210437-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210437-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210437-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210437-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210437-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210437-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210437-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210437-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210437-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210437-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210437-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210437-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210437-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210437-002AP1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f63639fe-3389-4c7a-8765-a6005a965c6cProduct name920260316

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71479-004-10Rocuronium bromide10 in 1 BOXINJECTION, SOLUTION102
71479-004-10Rocuronium bromide10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71479-004ROCURONIUM BROMIDE INJECTION, SOLUTION [SANOVEL ILAC SAN. VE TIC.A.S.]2Legacy NDC, 2 package rows20191231_ba999c24-fe3c-4d8f-981f-17d8639bc16b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RocuroniumROCURONIUMBryant Ranch Prepack6045ed5a-5d2c-4f17-aaba-458fbf87e85c2026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210437
application number: ANDA210437
RocuroniumROCURONIUMMedical Purchasing Solutions, LLC.41efca22-7a40-91b1-e063-6294a90a80182025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210437
application number: ANDA210437
RocuroniumROCURONIUMPiramal Critical Care Inc98255b70-51f9-8d16-e053-2995a90a8f972025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210437
application number: ANDA210437

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNba999c24-fe3c-4d8f-981f-17d8639bc16b2
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDba999c24-fe3c-4d8f-981f-17d8639bc16b2
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYba999c24-fe3c-4d8f-981f-17d8639bc16b2
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYba999c24-fe3c-4d8f-981f-17d8639bc16b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71479-004-107147900041010 in 1 BOXHistorical