FDA.reportPublic FDA data

Succinylcholine Chloride

Product NDC
82449-232
11-digit product format
824490232
Labeler code
82449
Product ID
82449-232_462126b7-5b86-7c83-e063-6394a90aa638
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Succinylcholine Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
STERISCIENCE SPECIALTIES PRIVATE LIMITED
Application
ANDA217873
Marketing category
ANDA
Marketing start
2024-09-30
Substance
SUCCINYLCHOLINE CHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217873-001SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDE100MG/5ML (20MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2024-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217873-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217873-001SUCCINYLCHOLINE CHLORIDE100MG/5ML (20MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUSAP2024-07-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217873-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDESTERISCIENCE SPECIALTIES PRIVATE LIMITED1d4302db-a0d5-d0e8-e063-6294a90a22f82025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217873
application number: ANDA217873
ndc (product): 82449-232

Additional Listing Data#

Finished product
Yes
Brand name base
Succinylcholine Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUCCINYLCHOLINE CHLORIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I9L0DDD30IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2598128Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d4302db-a0d5-d0e8-e063-6294a90a22f8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
abec1884-7093-4c95-8f57-c796012d60d8Product name220251120
810467f4-1d2b-8d95-dd9c-71dda6d03514Product name920250331
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82449-232-01Succinylcholine Chloride5 mL in 1 SYRINGEINJECTION, SOLUTION52
82449-232-02Succinylcholine Chloride10 in 1 PACKAGEINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82449-232SUCCINYLCHOLINE CHLORIDE INJECTION, SOLUTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED]1Current NDC, 2 package rows20241001_1d4302db-a0d5-d0e8-e063-6294a90a22f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2598128succinylcholine chloride 100 MG in 5 ML Prefilled SyringePSN1d4302db-a0d5-d0e8-e063-6294a90a22f82
25981285 ML succinylcholine chloride 20 MG/ML Prefilled SyringeSCD1d4302db-a0d5-d0e8-e063-6294a90a22f82
2598128succinylcholine chloride 100 MG per 5 ML Prefilled SyringeSY1d4302db-a0d5-d0e8-e063-6294a90a22f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82449-232-01824490232015 mL in 1 SYRINGE5 mlHistorical
82449-232-028244902320210 SYRINGE in 1 PACKAGE (82449-232-02) / 5 mL in 1 SYRINGE (82449-232-01) 10 syringe2024-09-30NoNoCurrent