FDA.reportPublic FDA data

Heparin Sodium

Product NDC
68083-136
11-digit product format
680830136
Labeler code
68083
Product ID
68083-136_794ab494-666a-4e82-ba24-982189a20255
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Gland Pharma Limited
Application
ANDA205323
Marketing category
ANDA
Marketing start
2017-03-09
Substance
HEPARIN SODIUM
Active strength
5000 [USP'U]/mL
Pharmacologic classes
Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Heparin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM5000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1361226, 1361615

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68083-136-252024-01-30C16284748780-11030e365-00c1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HEPARIN SODIUM INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM INJECTION. HEPARIN SODIUM injection, for intravenous or subcutaneous use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-136-01Heparin Sodium1 mL in 1 VIALINJECTION112
68083-136-25Heparin Sodium25 in 1 CARTONINJECTION2512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-136HEPARIN SODIUM INJECTION [GLAND PHARMA LIMITED]12Current NDC, Legacy NDC, 2 package rows20241119_301b19bc-21c2-4a35-9d29-569b08d855c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN301b19bc-21c2-4a35-9d29-569b08d855c412
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSN301b19bc-21c2-4a35-9d29-569b08d855c412
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD301b19bc-21c2-4a35-9d29-569b08d855c412
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCD301b19bc-21c2-4a35-9d29-569b08d855c412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-136-01680830136011 mL in 1 VIAL1 mlHistorical
68083-136-256808301362525 VIAL in 1 CARTON (68083-136-25) / 1 mL in 1 VIAL (68083-136-01) 25 vial2017-03-090000-00-00NoNoCurrent