FDA.reportPublic FDA data

Heparin Sodium

Product NDC
0409-7650
11-digit product format
004097650
Labeler code
0409
Product ID
0409-7650_d0901cbd-34c8-44e8-ba05-8b84952a862c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA018916
Marketing category
NDA
Marketing start
2005-06-30
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
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1658717, 1659195, 1659196, 1659197

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-7650-05Heparin Sodium250 mL in 1 BAGINJECTION, SOLUTION25031
0409-7650-30Heparin Sodium30 in 1 CASEINJECTION, SOLUTION3031
0409-7650-30Heparin Sodium1 in 1 POUCHINJECTION, SOLUTION131
0409-7650-52Heparin Sodium250 mL in 1 BAGINJECTION, SOLUTION25031
0409-7650-62Heparin Sodium24 in 1 CASEINJECTION, SOLUTION2431
0409-7650-62Heparin Sodium1 in 1 POUCHINJECTION, SOLUTION131

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-7650-05ML - Milliliter0409-7650748afbdf-afaf-4fef-8bd8-c7769912784712023-02-06
0409-7650-30ML - Milliliter0409-76501973048a-065f-4203-8ea2-2628610693dc12023-02-06
0409-7650-52ML - Milliliter0409-7650945ef35f-8242-4422-ac07-8c9aa140849512015-04-03
0409-7650-62ML - Milliliter0409-76504922d0b1-3e73-40fb-b070-83ca5064770512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPARIN SODIUMACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]13
HEPARINACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]13
EDETATE DISODIUM ANHYDROUSINACTIVE INGREDIENT8NLQ36F6MMHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-7650HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]28Current NDC, Legacy NDC, 6 package rows20241105_0413f511-6b34-4c15-e48b-3fad08baacbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659197heparin sodium, porcine 12,500 UNT in 250 ML InjectionPSN0413f511-6b34-4c15-e48b-3fad08baacbe31
1658717heparin sodium, porcine 25,000 UNT in 250 ML InjectionPSN0413f511-6b34-4c15-e48b-3fad08baacbe31
1659195heparin sodium, porcine 25,000 UNT in 500 ML InjectionPSN0413f511-6b34-4c15-e48b-3fad08baacbe31
1658717250 ML heparin sodium, porcine 100 UNT/ML InjectionSCD0413f511-6b34-4c15-e48b-3fad08baacbe31
1659197250 ML heparin sodium, porcine 50 UNT/ML InjectionSCD0413f511-6b34-4c15-e48b-3fad08baacbe31
1659195500 ML heparin sodium, porcine 50 UNT/ML InjectionSCD0413f511-6b34-4c15-e48b-3fad08baacbe31
1659196heparin sodium, porcine 50 UNT/ML InjectionSCD0413f511-6b34-4c15-e48b-3fad08baacbe31
1659197heparin sodium, porcine 12,500 UNT per 250 ML InjectionSY0413f511-6b34-4c15-e48b-3fad08baacbe31
1658717heparin sodium, porcine 25,000 UNT per 250 ML InjectionSY0413f511-6b34-4c15-e48b-3fad08baacbe31
1659195heparin sodium, porcine 25,000 UNT per 500 ML InjectionSY0413f511-6b34-4c15-e48b-3fad08baacbe31
1658717heparin sodium, porcine 25,000 UNT in 250 ML InjectionPSN97183edd-fa5c-8ff1-e053-2995a90ae1d55
1658717250 ML heparin sodium, porcine 100 UNT/ML InjectionSCD97183edd-fa5c-8ff1-e053-2995a90ae1d55
1658717heparin sodium, porcine 25,000 UNT per 250 ML InjectionSY97183edd-fa5c-8ff1-e053-2995a90ae1d55
1658717heparin sodium, porcine 25,000 UNT in 250 ML InjectionPSN51197aa6-de34-3a55-e063-6294a90a89c91
1658717250 ML heparin sodium, porcine 100 UNT/ML InjectionSCD51197aa6-de34-3a55-e063-6294a90a89c91
1658717heparin sodium, porcine 25,000 UNT per 250 ML InjectionSY51197aa6-de34-3a55-e063-6294a90a89c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-7650-0500409765005250 mL in 1 BAG250 mlHistorical
0409-7650-300040976503030 POUCH in 1 CASE (0409-7650-30) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-7650-05) 30 pouch2023-01-30NoNoCurrent
0409-7650-5200409765052250 mL in 1 BAG250 mlHistorical
0409-7650-620040976506224 POUCH in 1 CASE (0409-7650-62) > 1 BAG in 1 POUCH > 250 mL in 1 BAG (0409-7650-52) 24 pouch2005-06-300000-00-00NoNoCurrent