FDA.reportPublic FDA data

Heparin Sodium

Product NDC
0409-2222
11-digit product format
004092222
Labeler code
0409
Product ID
0409-2222_ecaae7d2-a76e-4eca-b045-6c88d7c2ab8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA018916
Marketing category
NDA
Marketing start
2023-02-27
Substance
HEPARIN SODIUM
Active strength
200 [USP'U]/100mL
Pharmacologic classes
Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM200 [USP'U]/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1658690, 1658691, 1658692

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac74f96-3910-44b9-8551-036880fbb1fbProduct name120260108
0a18eae4-4259-42db-86b6-915f66e83b06Product name120250729
2c999b01-2a13-4eff-8eb4-00b87316ef79Product name120231116
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-2222-01Heparin Sodium1000 mL in 1 BAGINJECTION, SOLUTION100034
0409-2222-12Heparin Sodium1 in 1 POUCHINJECTION, SOLUTION134
0409-2222-12Heparin Sodium12 in 1 CASEINJECTION, SOLUTION1234

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2222-01ML - Milliliter0409-22229c1e0a7c-59c7-4087-bcfd-d5ac72d189b812023-03-13
0409-2222-12ML - Milliliter0409-22222ddfe4c7-4c9a-494f-9ca5-66013a6d283812023-03-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPARIN SODIUMACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]15
HEPARINACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]15
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINACTIVE INGREDIENT70WT22SF4BHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]15
WATERINACTIVE INGREDIENT059QF0KO0RHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2222HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]31Current NDC, 3 package rows20241127_32e34077-aff1-4ec7-f9b0-b8e240768fb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658692heparin sodium, porcine 1000 UNT in 500 ML InjectionPSN32e34077-aff1-4ec7-f9b0-b8e240768fb834
1658690heparin sodium, porcine 2000 UNT in 1000 ML InjectionPSN32e34077-aff1-4ec7-f9b0-b8e240768fb834
16586901000 ML heparin sodium, porcine 2 UNT/ML InjectionSCD32e34077-aff1-4ec7-f9b0-b8e240768fb834
1658692500 ML heparin sodium, porcine 2 UNT/ML InjectionSCD32e34077-aff1-4ec7-f9b0-b8e240768fb834
1658691heparin sodium, porcine 2 UNT/ML InjectionSCD32e34077-aff1-4ec7-f9b0-b8e240768fb834
1658692heparin sodium, porcine 1000 UNT per 500 ML InjectionSY32e34077-aff1-4ec7-f9b0-b8e240768fb834
1658690heparin sodium, porcine 2000 UNT per 1000 ML InjectionSY32e34077-aff1-4ec7-f9b0-b8e240768fb834

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-2222-01004092222011000 mL in 1 BAG1000 mlHistorical
0409-2222-120040922221212 POUCH in 1 CASE (0409-2222-12) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (0409-2222-01) 12 pouch2023-02-27NoNoCurrent