FDA.reportPublic FDA data

Streptomycin

Product NDC
39822-0706
11-digit product format
398220706
Labeler code
39822
Product ID
39822-0706_48eb47bf-4135-a8cf-e063-6394a90a4d2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Streptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA064210
Marketing category
ANDA
Marketing start
1998-06-30
Substance
STREPTOMYCIN SULFATE
Active strength
1 g/1
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antimycobacterial [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STREPTOMYCIN SULFATE1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCW25IKJ202
Rxcui313115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-0706-1Streptomycin1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,115
39822-0706-2Streptomycin10 in 1 BOXINJECTION, POWDER, LYOPHILIZED,1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0706-1EA - Each39822-07063fa3759d-8c20-448d-98d2-a5c16a0b032212012-07-24
39822-0706-2EA - Each39822-0706711ff110-f108-41a2-998c-ad2bc9d727cc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STREPTOMYCIN SULFATEACTIVE INGREDIENTCW25IKJ202STREPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]8
STREPTOMYCINACTIVE MOIETYY45QSO73OBSTREPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-0706STREPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]13Current NDC, Legacy NDC, 2 package rows20230823_abd1f64e-4283-4370-aae8-3666316aa36e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313115streptomycin 1 GM InjectionPSNabd1f64e-4283-4370-aae8-3666316aa36e15
313115streptomycin 1000 MG InjectionSCDabd1f64e-4283-4370-aae8-3666316aa36e15
313115streptomycin (as streptomycin sulfate) 1000 MG InjectionSYabd1f64e-4283-4370-aae8-3666316aa36e15
313115streptomycin 1 GM InjectionSYabd1f64e-4283-4370-aae8-3666316aa36e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-0706-1398220706011 in 1 VIALHistorical
39822-0706-23982207060210 VIAL in 1 BOX (39822-0706-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (39822-0706-1) 10 vial1998-06-300000-00-00NoNoCurrent