FDA.reportPublic FDA data

Rocuronium Bromide

Product NDC
82449-001
11-digit product format
824490001
Labeler code
82449
Product ID
82449-001_77cc97bc-4ea2-414f-bbf7-8eaaca4c1eae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rocuronium Bromide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
STERISCIENCE SPECIALTIES PRIVATE LIMITED
Application
ANDA217092
Marketing category
ANDA
Marketing start
2024-11-30
Substance
ROCURONIUM BROMIDE
Active strength
50 mg/5mL
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 Bromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROCURONIUM BROMIDE50 mg/5mL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82449-001-01Rocuronium Bromide5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52
82449-001-02Rocuronium Bromide10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82449-001ROCURONIUM BROMIDE INJECTION, SOLUTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED]2Current NDC, 2 package rows20250124_b894c436-ea67-407e-a801-f334a0c0c2d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234995rocuronium bromide 10 MG/ML Injectable SolutionPSNb894c436-ea67-407e-a801-f334a0c0c2d92
1234995rocuronium bromide 10 MG/ML Injectable SolutionSCDb894c436-ea67-407e-a801-f334a0c0c2d92
1234995rocuronium bromide 100 MG per 10 ML Concentrate for Injectable SolutionSYb894c436-ea67-407e-a801-f334a0c0c2d92
1234995rocuronium bromide 50 MG per 5 ML Concentrate for Injectable SolutionSYb894c436-ea67-407e-a801-f334a0c0c2d92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82449-001-01824490001015 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
82449-001-028244900010210 VIAL, MULTI-DOSE in 1 CARTON (82449-001-02) / 5 mL in 1 VIAL, MULTI-DOSE (82449-001-01) 2024-11-30NoNoHistorical