FDA.reportPublic FDA data

NDC 70594-112-01 - Carboprost Tromethamine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70594-112
Requested NDC
70594-112-01
Package NDCs from labels
70594-112-01, 70594-112-02
Manufacturer
Xellia Pharmaceuticals USA LLC | Steriscience Pte. Limited | Stelis Biopharma Limited
Effective date
2023-11-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Carboprost Tromethamine Injection, USPXellia Pharmaceuticals USA LLC | Steriscience Pte. Limited | Stelis Biopharma Limited2023-11-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70594-112-01Carboprost Tromethamine1 mL in 1 VIALSOLUTION12
70594-112-02Carboprost Tromethamine10 in 1 CARTONSOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-112CARBOPROST TROMETHAMINE SOLUTION [XELLIA PHARMACEUTICALS USA LLC]2Current NDC, 2 package rows20231108_8a1284cf-002f-4887-a3c0-d73d04b2b869.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-112-01ML - Milliliter70594-1128a616d81-cdb1-461d-909f-5a70ea3f6fad12024-02-14
70594-112-02ML - Milliliter70594-112d16e2a4c-f4d3-4011-9101-8afdfdd2e95912024-02-14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
carboprost tromethamineCARBOPROST TROMETHAMINESomerset Therapeutics, LLCd79f4342-2d37-4a47-958e-ab800d4f39182026-06-05Boxed warning, Adverse reactionsExact identifier
unii: U4526F86FJ
HemabateCARBOPROST TROMETHAMINEPharmacia & Upjohn Company LLC3d282998-ff0c-480a-bd80-155606ef0a652026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
CARBOPROST TROMETHAMINECARBOPROST TROMETHAMINEOmnivium Pharmaceuticals LLC84efd1c0-6323-4469-9535-237f96fcb3832026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
Carboprost TromethamineCARBOPROST TROMETHAMINEHikma Pharmaceuticals USA Inc.aa42587d-7213-4a46-9050-9bbfbb081de52026-03-04Warnings, Adverse reactionsExact identifier
application number: ANDA216897
rxcui: 238014
unii: U4526F86FJ
CARBOPROST TROMETHAMINECARBOPROST TROMETHAMINEAlembic Pharmaceuticals Limitedd74a448c-ba91-4490-8550-9e675c39b4272025-12-15Warnings, Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
carboprost tromethamineCARBOPROST TROMETHAMINESOLA Pharmaceuticals, LLC32cb34f5-e199-4cf8-a848-aaec7d42bd102025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
CARBOPROST TROMETHAMINECARBOPROST TROMETHAMINEAlembic Pharmaceuticals Inc.c1cde9c7-b005-484f-8497-343c5ecd4f0a2025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
Carboprost TromethamineCARBOPROST TROMETHAMINESagent Pharmaceuticalsffc3a941-4d73-4273-a879-1565133a4d5d2025-12-02Boxed warning, Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
carboprost tromethamineCARBOPROST TROMETHAMINEAmneal Pharmaceuticals LLCeac3fd1c-ca4b-4aa3-9dc2-e7dbeb4c122a2025-10-31Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
CARBOPROST TROMETHAMINECARBOPROST TROMETHAMINEEugia US LLCa4c3b724-8c36-4d18-86b1-5ecee40cfbf42025-10-23Warnings, Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
Carboprost TromethamineCARBOPROST TROMETHAMINEONESOURCE SPECIALTY PHARMA LIMITED461f80d0-b66c-f093-e063-6294a90a88932025-08-29Boxed warning, Adverse reactionsExact identifier
application number: ANDA216897
rxcui: 238014
unii: U4526F86FJ
Carboprost TromethamineCARBOPROST TROMETHAMINEDr. Reddy's Laboratories Inc.ce9f0ea6-69f9-6b68-2811-3b51e34acea62025-03-19Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
CARBOPROST TROMETHAMINECARBOPROST TROMETHAMINECaplin Steriles Limited42736d6a-0ab3-4c3c-897d-406aad5a49c22025-01-20Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
Carboprost TromethamineCARBOPROST TROMETHAMINEANI Pharmaceuticals, Inc.4dcda284-cfea-4b95-b432-a3d5af536e632024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
CARBOPROST TROMETHAMINECARBOPROST TROMETHAMINEDr. Reddys Laboratories Inc.2fd306a6-bf50-a354-46e5-d9fa8da619af2024-12-20Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
CARBOPROST TROMETHAMINECARBOPROST TROMETHAMINEDr. Reddys Laboratories Inc.1fc164ae-9964-17b3-4b92-d25b0ddb805e2024-12-19Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
carboprost tromethamineCARBOPROST TROMETHAMINEHospira, Inc.e5054c6a-c54e-4ddf-8280-a154b90cac072024-04-15Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
Carboprost TromethamineCARBOPROST TROMETHAMINEMicro Labs Limiteda8a6acbf-81db-4fe3-aec8-ee7aa7af4d322024-04-05Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ
Carboprost TromethamineCARBOPROST TROMETHAMINEXellia Pharmaceuticals USA LLC8a1284cf-002f-4887-a3c0-d73d04b2b8692023-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA216897
ndc (package): 70594-112-02
ndc (package): 70594-112-01
ndc (product): 70594-112
ndc11 (package): 70594011201
rxcui: 238014
spl id: 855a4bbb-d273-4372-8221-8fcff32bee92
spl set id: 8a1284cf-002f-4887-a3c0-d73d04b2b869
unii: U4526F86FJ
carboprost tromethamineCARBOPROST TROMETHAMINEGland Pharma Limited5902edd8-16b3-4f52-ac35-b0f4dfb5ab6a2023-08-08Adverse reactionsExact identifier
rxcui: 238014
unii: U4526F86FJ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.