FDA.reportPublic FDA data

Hemabate

Product NDC
0009-0856
11-digit product format
000090856
Labeler code
0009
Product ID
0009-0856_7321f382-9653-4cdb-99ac-96384dd06abb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carboprost tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA017989
Marketing category
NDA
Marketing start
1979-01-09
Substance
CARBOPROST TROMETHAMINE
Active strength
250 ug/mL
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBOPROST TROMETHAMINE250 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU4526F86FJ
Rxcui213638, 238014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
bf7dbc85-c3be-ce3e-e49f-8b9d8ea1ff7cProduct name520240515
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-0856-05Hemabate1 mL in 1 AMPULEINJECTION, SOLUTION114
0009-0856-08Hemabate10 in 1 PACKAGEINJECTION, SOLUTION1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0856-05ML - Milliliter0009-085695296270-074a-43ea-ab7b-5e249e9b85b212013-04-01
0009-0856-08ML - Milliliter0009-08567de565f8-5687-49b0-bea5-347caec7fb7712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBOPROST TROMETHAMINEACTIVE INGREDIENTU4526F86FJHEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]6
CARBOPROSTACTIVE MOIETY7B5032XT6OHEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]6
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VHEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0856HEMABATE (CARBOPROST TROMETHAMINE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]12Current NDC, Legacy NDC, 2 package rows20250406_3d282998-ff0c-480a-bd80-155606ef0a65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238014carboprost tromethamine 250 MCG in 1 ML InjectionPSN3d282998-ff0c-480a-bd80-155606ef0a6514
213638Hemabate 250 MCG in 1 ML InjectionPSN3d282998-ff0c-480a-bd80-155606ef0a6514
2136381 ML carboprost 0.25 MG/ML Injection [Hemabate]SBD3d282998-ff0c-480a-bd80-155606ef0a6514
2380141 ML carboprost 0.25 MG/ML InjectionSCD3d282998-ff0c-480a-bd80-155606ef0a6514
2136381 ML Hemabate 0.25 MG/ML InjectionSY3d282998-ff0c-480a-bd80-155606ef0a6514
238014carboprost 250 MCG per 1 ML InjectionSY3d282998-ff0c-480a-bd80-155606ef0a6514
213638Hemabate 250 MCG per 1 ML InjectionSY3d282998-ff0c-480a-bd80-155606ef0a6514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0856-05000090856051 mL in 1 AMPULE (0009-0856-05) 1 ml1979-01-090000-00-00NoNoCurrent
0009-0856-080000908560810 AMPULE in 1 PACKAGE (0009-0856-08) / 1 mL in 1 AMPULE (0009-0856-05) 10 ampule1979-01-090000-00-00NoNoCurrent