FDA.reportPublic FDA data

Heparin Sodium and Dextrose

Product NDC
0409-4520
11-digit product format
004094520
Labeler code
0409
Product ID
0409-4520_b2a0ec6b-eee0-46b9-9e8a-ae2442e30771
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA019339
Marketing category
NDA
Marketing start
2022-12-12
Substance
HEPARIN SODIUM
Active strength
10000 [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 and Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM10000 [USP'U]/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1658717

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4520-02Heparin Sodium and Dextrose250 mL in 1 BAGINJECTION, SOLUTION25035
0409-4520-30Heparin Sodium and Dextrose30 in 1 CASEINJECTION, SOLUTION3035
0409-4520-30Heparin Sodium and Dextrose1 in 1 POUCHINJECTION, SOLUTION135

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4520-02ML - Milliliter0409-4520f5c76cd4-f5f9-4c80-a432-0d369f652ddb12023-01-09
0409-4520-30ML - Milliliter0409-452046269ff8-ea8d-46b3-8eff-8f08f30b655d12023-01-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPARIN SODIUMACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM) INJECTION, SOLUTION [HOSPIRA, INC.]16
HEPARINACTIVE MOIETYT2410KM04AHEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM) INJECTION, SOLUTION [HOSPIRA, INC.]16
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM) INJECTION, SOLUTION [HOSPIRA, INC.]16
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GHEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM) INJECTION, SOLUTION [HOSPIRA, INC.]16
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CHEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM) INJECTION, SOLUTION [HOSPIRA, INC.]16
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KHEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM) INJECTION, SOLUTION [HOSPIRA, INC.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4520HEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM) INJECTION, SOLUTION [HOSPIRA, INC.]31Current NDC, Legacy NDC, 3 package rows20241201_eede8a0c-5ae6-4166-84b3-12081405f08e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658717heparin sodium, porcine 25,000 UNT in 250 ML InjectionPSNeede8a0c-5ae6-4166-84b3-12081405f08e35
1658717250 ML heparin sodium, porcine 100 UNT/ML InjectionSCDeede8a0c-5ae6-4166-84b3-12081405f08e35
1658717heparin sodium, porcine 25,000 UNT per 250 ML InjectionSYeede8a0c-5ae6-4166-84b3-12081405f08e35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4520-0200409452002250 mL in 1 BAG250 mlHistorical
0409-4520-300040945203030 POUCH in 1 CASE (0409-4520-30) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-4520-02) 30 pouch2022-12-120000-00-00NoNoCurrent