Rocuronium

Product NDC
71872-7349
11-digit product format
718727349
Labeler code
71872
Product ID
71872-7349_41efca22-7a41-91b1-e063-6294a90a8018
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rocuronium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC.
Application
ANDA210437
Marketing category
ANDA
Marketing start
2020-07-20
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
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 · 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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROCURONIUM BROMIDE100 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I65MW4OFHZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234995Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
41efca22-7a40-91b1-e063-6294a90a8018Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f63639fe-3389-4c7a-8765-a6005a965c6cProduct name920260316
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7349-1Rocuronium1 in 1 BAGINJECTION, SOLUTION11
71872-7349-1Rocuronium10 mL in 1 VIALINJECTION, SOLUTION101

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
ndc (product): 71872-7349
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 SolutionPSN41efca22-7a40-91b1-e063-6294a90a80181
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCD41efca22-7a40-91b1-e063-6294a90a80181
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSY41efca22-7a40-91b1-e063-6294a90a80181
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSY41efca22-7a40-91b1-e063-6294a90a80181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71872-7349-1718727349011 VIAL in 1 BAG (71872-7349-1) / 10 mL in 1 VIAL1 vial2025-04-21NoNoCurrent