FDA.reportPublic FDA data

Rocuronium

Product NDC
81565-204
11-digit product format
815650204
Labeler code
81565
Product ID
81565-204_7297a261-1b67-4281-bd1d-80a366cb446e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROCURONIUM BROMIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Phlow Corporation
Application
ANDA078651
Marketing category
ANDA
Marketing start
2022-02-08
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROCURONIUM BROMIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI65MW4OFHZ
Rxcui1234995

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81565-204-022024-02-22C16284748780-11030e365-50d8-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROCURONIUM BROMIDE INJECTION safely and effectively. See full prescribing information for ROCURONIUM BROMIDE INJECTION. ROCURONIUM BROMIDE injection, for intravenous use Initial U.S. Approval: 1994
81565-204-022024-01-30C16284748780-11030e365-50d8-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROCURONIUM BROMIDE INJECTION safely and effectively. See full prescribing information for ROCURONIUM BROMIDE INJECTION. ROCURONIUM BROMIDE injection, for intravenous use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81565-204-01Rocuronium5 mL in 1 VIALINJECTION, SOLUTION53
81565-204-02Rocuronium10 in 1 TRAYINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81565-204-02ML - Milliliter81565-204d65287d6-1952-4500-82db-225572b2042312022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81565-204ROCURONIUM (ROCURONIUM BROMIDE) INJECTION, SOLUTION [PHLOW CORPORATION]3Current NDC, Legacy NDC, 2 package rows20240415_ad34ecc7-ff1f-4ee5-a235-e453873d0313.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNad34ecc7-ff1f-4ee5-a235-e453873d03133
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDad34ecc7-ff1f-4ee5-a235-e453873d03133
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYad34ecc7-ff1f-4ee5-a235-e453873d03133
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYad34ecc7-ff1f-4ee5-a235-e453873d03133

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81565-204-01815650204015 mL in 1 VIAL5 mlHistorical
81565-204-028156502040210 VIAL in 1 TRAY (81565-204-02) / 5 mL in 1 VIAL (81565-204-01) 10 vial2022-02-080000-00-00NoNoCurrent