FDA.reportPublic FDA data

Protamine Sulfate

Product NDC
63323-229
11-digit product format
633230229
Labeler code
63323
Product ID
63323-229_1e6b19d0-9376-4cec-9eef-fea441e0263e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROTAMINE SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA089454
Marketing category
ANDA
Marketing start
2000-10-18
Substance
PROTAMINE SULFATE
Active strength
10 mg/mL
Pharmacologic classes
Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Protamine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROTAMINE SULFATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0DE9724IHC
Rxcui1796672, 1796676

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-229-01Protamine Sulfate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION56
63323-229-05Protamine Sulfate25 in 1 TRAYINJECTION, SOLUTION256
63323-229-30Protamine Sulfate1 in 1 BOXINJECTION, SOLUTION16
63323-229-30Protamine Sulfate25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION256
63323-229-41Protamine Sulfate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION55
63323-229-94Protamine Sulfate25 in 1 TRAYINJECTION, SOLUTION255
63323-229-95Protamine Sulfate1 in 1 BOXINJECTION, SOLUTION15
63323-229-95Protamine Sulfate25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION255
63323-229-15Protamine Sulfate25 in 1 TRAYINJECTION, SOLUTION254
63323-229-21Protamine Sulfate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION54
63323-229-26Protamine Sulfate10 in 1 TRAYINJECTION, SOLUTION104
63323-229-26Protamine Sulfate25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION254
63323-229-35Protamine Sulfate1 in 1 BOXINJECTION, SOLUTION14
63323-229-35Protamine Sulfate25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-229-01ML - Milliliter63323-229b248cdf3-93bc-4a84-89e5-acea106e1a1212024-10-04
63323-229-05ML - Milliliter63323-229032fd5ba-1f3c-4e1d-81b9-3705c5841b0512013-02-13
63323-229-15ML - Milliliter63323-2292b208c91-45ce-470d-b2a9-437acb3c8b3412014-06-03
63323-229-21ML - Milliliter63323-22964344195-578b-4a40-87c9-ef9de67820bf12019-08-06
63323-229-30ML - Milliliter63323-2295ea5d8d6-1de7-4af5-8c1b-e0894a56e10212013-02-13
63323-229-35ML - Milliliter63323-22940a33f29-25b5-4fda-8cf5-4d72172bfde512014-06-03
63323-229-41ML - Milliliter63323-22967a8c4b7-7114-4679-865f-5d31482ba3f312019-10-07
63323-229-94ML - Milliliter63323-2299bb4f4fa-de32-40f2-84d9-2d9bb18aefa412014-07-02
63323-229-95ML - Milliliter63323-2292b1c90ae-0261-4707-93c4-ade581e8110912014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROTAMINE SULFATEACTIVE INGREDIENT0DE9724IHCPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
PROTAMINEACTIVE MOIETY72G3UY6T4NPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
PROTAMINE SULFATEACTIVE INGREDIENT0DE9724IHCPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PROTAMINE SULFATEACTIVE INGREDIENT0DE9724IHCPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PROTAMINEACTIVE MOIETY72G3UY6T4NPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PROTAMINEACTIVE MOIETY72G3UY6T4NPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-229PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 4 package rows20250214_e1964129-33f4-4e4e-86e3-8e6a4e65bd83.zip
63323-229PROTAMINE SULFATE (PROTAMINE SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 4 package rows20240208_8df0a819-9e1a-44ce-97a6-3ea82c867d44.zip
63323-229PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 6 package rows20240402_7a31fc4c-579f-45cc-9559-39cfad9a57b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1796676protamine sulfate 250 MG in 25 ML InjectionPSNe1964129-33f4-4e4e-86e3-8e6a4e65bd836
1796672protamine sulfate 50 MG in 5 ML InjectionPSNe1964129-33f4-4e4e-86e3-8e6a4e65bd836
179667625 ML protamine sulfate (USP) 10 MG/ML InjectionSCDe1964129-33f4-4e4e-86e3-8e6a4e65bd836
17966725 ML protamine sulfate (USP) 10 MG/ML InjectionSCDe1964129-33f4-4e4e-86e3-8e6a4e65bd836
1796676protamine sulfate 250 MG per 25 ML InjectionSYe1964129-33f4-4e4e-86e3-8e6a4e65bd836
1796672protamine sulfate 50 MG per 5 ML InjectionSYe1964129-33f4-4e4e-86e3-8e6a4e65bd836
1796676protamine sulfate 250 MG in 25 ML InjectionPSN8df0a819-9e1a-44ce-97a6-3ea82c867d445
1796672protamine sulfate 50 MG in 5 ML InjectionPSN8df0a819-9e1a-44ce-97a6-3ea82c867d445
179667625 ML protamine sulfate (USP) 10 MG/ML InjectionSCD8df0a819-9e1a-44ce-97a6-3ea82c867d445
17966725 ML protamine sulfate (USP) 10 MG/ML InjectionSCD8df0a819-9e1a-44ce-97a6-3ea82c867d445
1796676protamine sulfate 250 MG per 25 ML InjectionSY8df0a819-9e1a-44ce-97a6-3ea82c867d445
1796672protamine sulfate 50 MG per 5 ML InjectionSY8df0a819-9e1a-44ce-97a6-3ea82c867d445
1796676protamine sulfate 250 MG in 25 ML InjectionPSN7a31fc4c-579f-45cc-9559-39cfad9a57b34
1796672protamine sulfate 50 MG in 5 ML InjectionPSN94d4f57f-940e-c0a8-e053-2a95a90ae3af4
1796672protamine sulfate 50 MG in 5 ML InjectionPSN7a31fc4c-579f-45cc-9559-39cfad9a57b34
179667625 ML protamine sulfate (USP) 10 MG/ML InjectionSCD7a31fc4c-579f-45cc-9559-39cfad9a57b34
17966725 ML protamine sulfate (USP) 10 MG/ML InjectionSCD94d4f57f-940e-c0a8-e053-2a95a90ae3af4
17966725 ML protamine sulfate (USP) 10 MG/ML InjectionSCD7a31fc4c-579f-45cc-9559-39cfad9a57b34
1796676protamine sulfate 250 MG per 25 ML InjectionSY7a31fc4c-579f-45cc-9559-39cfad9a57b34
1796672protamine sulfate 50 MG per 5 ML InjectionSY7a31fc4c-579f-45cc-9559-39cfad9a57b34
1796672protamine sulfate 50 MG per 5 ML InjectionSY94d4f57f-940e-c0a8-e053-2a95a90ae3af4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-229-01633230229015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
63323-229-056332302290525 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-01) 2000-10-180000-00-00NoNoCurrent
63323-229-156332302291525 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-15) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-21) 2000-10-180000-00-00NoNoCurrent
63323-229-21633230229215 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
63323-229-256332302292510 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-25) > 25 mL in 1 VIAL, SINGLE-DOSE2000-10-180000-00-00NoNoCurrent
63323-229-266332302292610 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-26) > 25 mL in 1 VIAL, SINGLE-DOSE2000-10-180000-00-00NoNoCurrent
63323-229-30633230229301 VIAL, SINGLE-DOSE in 1 BOX (63323-229-30) / 25 mL in 1 VIAL, SINGLE-DOSE2000-10-180000-00-00NoNoCurrent
63323-229-35633230229351 VIAL, SINGLE-DOSE in 1 BOX (63323-229-35) / 25 mL in 1 VIAL, SINGLE-DOSE2000-10-180000-00-00NoNoCurrent
63323-229-41633230229415 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
63323-229-946332302299425 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-94) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-41) 2000-10-180000-00-00NoNoCurrent
63323-229-95633230229951 VIAL, SINGLE-DOSE in 1 BOX (63323-229-95) / 25 mL in 1 VIAL, SINGLE-DOSE2000-10-180000-00-00NoNoCurrent