Rocuronium Bromide

Product NDC
47781-617
11-digit product format
477810617
Labeler code
47781
Product ID
47781-617_3eac2b48-3c72-dd52-a243-d3440e2ffbc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rocuronium bromide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Alvogen Inc.
Application
ANDA205656
Marketing category
ANDA
Marketing start
2018-04-27
Marketing end
2021-12-01
Substance
ROCURONIUM BROMIDE
Active strength
10 mg/mL
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct47781-617DDiscontinued by firm2026-08-11
excluded packagepackage47781-61747781-617-91DDiscontinued by firm2026-08-11

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 · 24 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 packagepackage47781-617-91d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage47781-617-91f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage47781-617-912ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage47781-617-91a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage47781-617-91cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage47781-617-91cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage47781-617-91302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage47781-617-91ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage47781-617-910efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage47781-617-91ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage47781-617-91367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage47781-617-91557ba5c1ecfa…9c80585c8c6e…

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
A205656-001ROCURONIUM BROMIDEROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-04
A205656-002ROCURONIUM BROMIDEROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205656-001AP
A205656-002AP

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAPRS2018-04-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205656-001ROCURONIUM BROMIDE50MG/5ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-04782e0a99824c…
2021-12-28 21:50 UTC2021-12A205656-002ROCURONIUM BROMIDE100MG/10ML (10MG/ML)INJECTABLE / INJECTIONAP2018-04-04782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205656-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205656-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205656-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205656-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205656-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205656-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205656-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205656-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205656-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205656-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205656-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205656-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205656-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205656-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205656-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205656-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205656-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205656-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205656-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205656-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205656-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205656-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205656-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205656-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205656-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205656-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205656-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205656-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205656-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205656-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205656-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205656-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205656-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205656-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205656-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205656-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205656-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205656-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205656-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205656-002AP1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-617-22ML - Milliliter47781-61746c4832d-691b-4d82-8bfa-247a1484e12312018-06-11
47781-617-91ML - Milliliter47781-6170e16b5a9-47b3-4a80-8628-0dacb6e23b7612018-06-11

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rocuronium BromideROCURONIUM BROMIDEProPharma Distribution579c4dfd-4877-33bb-e063-6394a90ae3d92026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205656
application number: ANDA205656
Rocuronium BromideROCURONIUM BROMIDEGland Pharma Limiteda223a740-dbe8-4d06-8b8b-d9104b694e622025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205656
application number: ANDA205656
ROCURONIUM BROMIDEROCURONIUM BROMIDEHF Acquisition Co LLC, DBA HealthFirst15897860-d6a9-07e5-e063-6394a90aec752024-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205656
application number: ANDA205656
ROCURONIUM BROMIDEROCURONIUM BROMIDEHF Acquisition Co LLC, DBA HealthFirst074abb29-72d9-b09f-e063-6294a90af0a92024-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205656
application number: ANDA205656
rocuronium bromideROCURONIUM BROMIDEHospira, Inc.f01f9986-43f9-40e8-9506-11bfe78f92422023-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205656
application number: ANDA205656
Rocuronium BromideROCURONIUM BROMIDESagent Pharmaceuticals01825411-be08-4402-b101-cb546291c9722023-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205656
application number: ANDA205656
rocuronium bromideROCURONIUM BROMIDEHospira, Inc.c96726ef-f1fa-4ebb-ba33-3479c3902a8e2023-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205656
application number: ANDA205656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-617-914778106179110 VIAL, MULTI-DOSE in 1 CARTON (47781-617-91) > 10 mL in 1 VIAL, MULTI-DOSE (47781-617-22) 2018-05-042021-12-01NoNoCurrent