FDA.reportPublic FDA data

Heparin Sodium

Product NDC
67457-385
11-digit product format
674570385
Labeler code
67457
Product ID
67457-385_0aca9c58-9720-420b-a0fa-3ef6c841f35c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Mylan Institutional LLC
Application
ANDA203851
Marketing category
ANDA
Marketing start
2018-03-16
Marketing end
2026-07-31
Substance
HEPARIN SODIUM
Active strength
1000 [USP'U]/mL
Pharmacologic classes
Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Heparin Sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM1000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1361226, 1361615, 1362831

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
67457-385-10Heparin Sodium10 mL in 1 VIAL, MULTI-DOSEINJECTION1010
67457-385-99Heparin Sodium25 in 1 CARTONINJECTION2510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-385-10ML - Milliliter67457-385bbb3948a-3b02-4198-bc7a-82558e5aad1712018-04-19
67457-385-99ML - Milliliter67457-3854d13b983-f2ee-4a56-ad49-bffed4afc3f812018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-385HEPARIN SODIUM INJECTION [MYLAN INSTITUTIONAL LLC]10Current NDC, Legacy NDC, 2 package rows20250501_88114716-5759-4bc9-8a85-d28da12962cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionPSN88114716-5759-4bc9-8a85-d28da12962cc10
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN88114716-5759-4bc9-8a85-d28da12962cc10
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSN88114716-5759-4bc9-8a85-d28da12962cc10
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD88114716-5759-4bc9-8a85-d28da12962cc10
1362831heparin sodium, porcine 10000 UNT/ML Injectable SolutionSCD88114716-5759-4bc9-8a85-d28da12962cc10
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCD88114716-5759-4bc9-8a85-d28da12962cc10
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionSY88114716-5759-4bc9-8a85-d28da12962cc10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-385-106745703851010 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
67457-385-996745703859925 VIAL, MULTI-DOSE in 1 CARTON (67457-385-99) / 10 mL in 1 VIAL, MULTI-DOSE (67457-385-10) 2018-03-162026-07-31NoNoCurrent