FDA.reportPublic FDA data

Protopam Chloride

Product NDC
60977-141
11-digit product format
609770141
Labeler code
60977
Product ID
60977-141_ce0e8c50-0a21-4dbe-bdc6-e64a26a120c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pralidoxime chloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Baxter Healthcare Corporation
Application
NDA014134
Marketing category
NDA
Marketing start
1965-03-10
Substance
PRALIDOXIME CHLORIDE
Active strength
1 g/20mL
Pharmacologic classes
Cholinesterase Reactivator [EPC], Cholinesterase Reactivators [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRALIDOXIME CHLORIDE1 g/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii38X7XS076H
Rxcui208969, 312576

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
0395ee9f-b6e0-2e52-6ab9-39f69ba534d5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60977-141-01Protopam Chloride6 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,615
60977-141-27Protopam Chloride20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,2015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60977-141-01EA - Each60977-141d5af37da-bdf1-425c-9bff-87ca8be75b3112012-07-24
60977-141-27EA - Each60977-141a9c49cb0-136b-46b5-8273-25400b4dd28112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRALIDOXIME CHLORIDEACTIVE INGREDIENT38X7XS076HPROTOPAM CHLORIDE (PRALIDOXIME CHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]5
PRALIDOXIMEACTIVE MOIETYP7MU9UTP52PROTOPAM CHLORIDE (PRALIDOXIME CHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROTOPAM CHLORIDE (PRALIDOXIME CHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60977-141PROTOPAM CHLORIDE (PRALIDOXIME CHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]14Current NDC, Legacy NDC, 2 package rows20250228_2741d8fd-51c2-46be-880b-99f2b20a6137.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312576pralidoxime chloride 1 GM InjectionPSN2741d8fd-51c2-46be-880b-99f2b20a613715
208969Protopam Chloride 1 GM InjectionPSN2741d8fd-51c2-46be-880b-99f2b20a613715
208969pralidoxime chloride 1000 MG Injection [Protopam]SBD2741d8fd-51c2-46be-880b-99f2b20a613715
312576pralidoxime chloride 1000 MG InjectionSCD2741d8fd-51c2-46be-880b-99f2b20a613715
312576pralidoxime chloride 1 GM InjectionSY2741d8fd-51c2-46be-880b-99f2b20a613715
208969Protopam 1 GM InjectionSY2741d8fd-51c2-46be-880b-99f2b20a613715
208969Protopam 1000 MG InjectionSY2741d8fd-51c2-46be-880b-99f2b20a613715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60977-141-01609770141016 VIAL, SINGLE-DOSE in 1 PACKAGE (60977-141-01) / 20 mL in 1 VIAL, SINGLE-DOSE (60977-141-27) 1965-03-100000-00-00NoNoCurrent
60977-141-276097701412720 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical