FDA.reportPublic FDA data

NDC 0591-3553 - Pitocin

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
0591-3553
Package NDCs from labels
0591-3553-69
Manufacturer
Watson Laboratories, Inc.
Effective date
2008-01-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pitocin - Watson Laboratories, Inc.Watson Laboratories, Inc.2008-01-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3553-69Pitocin1 mL in 1 VIALINJECTION11
0591-3553-69Pitocin25 in 1 PACKAGEINJECTION251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3553PITOCIN (OXYTOCIN) INJECTION [WATSON LABORATORIES, INC.]12 package rows20080208_8fbd0773-6645-4235-9ef2-56edf9c7fb83.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
oxytocinACTIVE INGREDIENT1JQS135EYNPITOCIN (OXYTOCIN) INJECTION [WATSON LABORATORIES, INC.]1
oxytocinACTIVE MOIETY1JQS135EYNPITOCIN (OXYTOCIN) INJECTION [WATSON LABORATORIES, INC.]1
acetic acidINACTIVE INGREDIENTQ40Q9N063PPITOCIN (OXYTOCIN) INJECTION [WATSON LABORATORIES, INC.]1
chlorobutanolINACTIVE INGREDIENTHM4YQM8WRCPITOCIN (OXYTOCIN) INJECTION [WATSON LABORATORIES, INC.]1

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 1 ยท 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxytocinOXYTOCINREMEDYREPACK INC.b6f20a2c-3609-4b09-b8f7-8d8eaeb5c2422026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 1791721
PitocinOXYTOCINPar Health USA, LLC969d5b35-0add-4c23-9605-6a5b6ab65c952026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791721
rxcui: 1791723
PitocinOXYTOCINPar Health USA, LLC6e5a66fc-e507-497c-b5ce-44a8c95898ad2026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791721
rxcui: 1791723
OxytocinOXYTOCINFresenius Kabi USA, LLCc7fd585a-99b7-4309-b003-a6cbef05372c2026-01-12Warnings, Adverse reactionsExact identifier
rxcui: 1791721
OxytocinOXYTOCINCardinal Health 107, LLC18fe8365-86e3-414e-84dc-c98e097a2f362025-06-20Warnings, Adverse reactionsExact identifier
rxcui: 1791721
OxytocinOXYTOCINFresenius Kabi USA, LLC4c4c4b69-8bf7-472c-aafe-29805ba5c9652025-03-24Warnings, Adverse reactionsExact identifier
rxcui: 1791721
OxytocinOXYTOCINFresenius Kabi USA, LLC6d7d1280-f286-4f39-89f3-2b96571810e62024-10-15Warnings, Adverse reactionsExact identifier
rxcui: 1791721
PitocinOXYTOCINPar Health USA, LLCdddcdcc3-cd4d-4573-98ac-9468bea23a8b2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791721
rxcui: 1791723
OxytocinOXYTOCINWest-Ward Pharmaceuticals Corpd16a48c5-6b71-40a0-bcda-204f043fe8322018-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791721
834100B2-7E70-75E8-4091-B9DEE349F0588fbd0773-6645-4235-9ef2-56edf9c7fb832008-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 834100B2-7E70-75E8-4091-B9DEE349F058
spl set id: 8fbd0773-6645-4235-9ef2-56edf9c7fb83

Reported adverse events (FAERS/openFDA)#

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