FDA.reportPublic FDA data

Fragmin

Product NDC
0069-0232
11-digit product format
000690232
Labeler code
0069
Product ID
0069-0232_af340f13-7954-4974-845d-ae55e0b56512
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dalteparin Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA020287
Marketing category
NDA
Marketing start
2015-04-01
Substance
DALTEPARIN SODIUM
Active strength
25000 [iU]/mL
Pharmacologic classes
Anti-coagulant [EPC], Heparin, Low-Molecular-Weight [CS], Low Molecular Weight 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
Fragmin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DALTEPARIN SODIUM25000 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii12M44VTJ7B
Rxcui978725, 978727, 978733, 978735, 978736, 978737, 978740, 978741, 978744, 978745, 978746, 978747, 978755, 978757, 978777, 978778, 2618839, 2618842

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
603b0afe-8b26-4c18-86ca-a17a3337c817Product name120190808
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct 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
0069-0232-01Fragmin1 in 1 CARTONINJECTION127
0069-0232-01Fragmin3.8 mL in 1 VIAL, MULTI-DOSEINJECTION3.827

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0232FRAGMIN (DALTEPARIN SODIUM) INJECTION [PFIZER LABORATORIES DIV PFIZER INC]26Current NDC, Legacy NDC, 2 package rows20241114_23527b8b-9b28-4e6d-9751-33b143975ac7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978755dalteparin sodium 10,000 UNT in 1 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
2618839dalteparin sodium 10,000 UNT in 4 ML InjectionPSN23527b8b-9b28-4e6d-9751-33b143975ac727
978740dalteparin sodium 12,500 UNT in 0.5 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
978744dalteparin sodium 15,000 UNT in 0.6 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
978746dalteparin sodium 18,000 UNT in 0.72 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
978777dalteparin sodium 25,000 UNT/ML Injectable SolutionPSN23527b8b-9b28-4e6d-9751-33b143975ac727
978725dalteparin sodium 2500 UNT in 0.2 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
978733dalteparin sodium 5000 UNT in 0.2 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
978736dalteparin sodium 7500 UNT in 0.3 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
978757Fragmin 10,000 UNT in 1 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
2618842Fragmin 10,000 UNT in 4 ML InjectionPSN23527b8b-9b28-4e6d-9751-33b143975ac727
978741Fragmin 12,500 UNT in 0.5 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
978745Fragmin 15,000 UNT in 0.6 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
978747Fragmin 18,000 UNT in 0.72 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
978778Fragmin 25,000 UNT/ML Injectable SolutionPSN23527b8b-9b28-4e6d-9751-33b143975ac727
978727Fragmin 2500 UNT in 0.2 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
978735Fragmin 5000 UNT in 0.2 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
978737Fragmin 7500 UNT in 0.3 ML Prefilled SyringePSN23527b8b-9b28-4e6d-9751-33b143975ac727
9787270.2 ML dalteparin sodium 12500 UNT/ML Prefilled Syringe [Fragmin]SBD23527b8b-9b28-4e6d-9751-33b143975ac727
9787350.2 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe [Fragmin]SBD23527b8b-9b28-4e6d-9751-33b143975ac727
9787370.3 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe [Fragmin]SBD23527b8b-9b28-4e6d-9751-33b143975ac727
9787410.5 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe [Fragmin]SBD23527b8b-9b28-4e6d-9751-33b143975ac727
9787450.6 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe [Fragmin]SBD23527b8b-9b28-4e6d-9751-33b143975ac727
9787470.72 ML dalteparin sodium 25000 UNT/ML Prefilled Syringe [Fragmin]SBD23527b8b-9b28-4e6d-9751-33b143975ac727
9787571 ML dalteparin sodium 10000 UNT/ML Prefilled Syringe [Fragmin]SBD23527b8b-9b28-4e6d-9751-33b143975ac727
26188424 ML dalteparin sodium 2500 UNT/ML Injection [Fragmin]SBD23527b8b-9b28-4e6d-9751-33b143975ac727
978778dalteparin sodium 25000 UNT/ML Injectable Solution [Fragmin]SBD23527b8b-9b28-4e6d-9751-33b143975ac727
9787250.2 ML dalteparin sodium 12500 UNT/ML Prefilled SyringeSCD23527b8b-9b28-4e6d-9751-33b143975ac727
9787330.2 ML dalteparin sodium 25000 UNT/ML Prefilled SyringeSCD23527b8b-9b28-4e6d-9751-33b143975ac727
9787360.3 ML dalteparin sodium 25000 UNT/ML Prefilled SyringeSCD23527b8b-9b28-4e6d-9751-33b143975ac727
9787400.5 ML dalteparin sodium 25000 UNT/ML Prefilled SyringeSCD23527b8b-9b28-4e6d-9751-33b143975ac727
9787440.6 ML dalteparin sodium 25000 UNT/ML Prefilled SyringeSCD23527b8b-9b28-4e6d-9751-33b143975ac727
9787460.72 ML dalteparin sodium 25000 UNT/ML Prefilled SyringeSCD23527b8b-9b28-4e6d-9751-33b143975ac727
9787551 ML dalteparin sodium 10000 UNT/ML Prefilled SyringeSCD23527b8b-9b28-4e6d-9751-33b143975ac727
26188394 ML dalteparin sodium 2500 UNT/ML InjectionSCD23527b8b-9b28-4e6d-9751-33b143975ac727
978777dalteparin sodium 25000 UNT/ML Injectable SolutionSCD23527b8b-9b28-4e6d-9751-33b143975ac727
9787270.2 ML Fragmin 12,500 UNT/ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
9787350.2 ML Fragmin 25000 UNT/ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
9787370.3 ML Fragmin 25000 UNT/ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
9787410.5 ML Fragmin 25,000 UNT/ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
9787450.6 ML Fragmin 25,000 UNT/ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
9787470.72 ML Fragmin 25,000 UNT/ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
9787571 ML Fragmin 10,000 UNT/ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
26188424 ML Fragmin 2500 UNT/ML InjectionSY23527b8b-9b28-4e6d-9751-33b143975ac727
2618839dalteparin sodium 10,000 UNT per 4 ML InjectionSY23527b8b-9b28-4e6d-9751-33b143975ac727
978755dalteparin sodium 10000 UNT/ML 1 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978740dalteparin sodium 12,500 UNT per 0.5 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978744dalteparin sodium 15,000 UNT per 0.6 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978746dalteparin sodium 18,000 UNT per 0.72 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978725dalteparin sodium 2500 UNT per 0.2 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978733dalteparin sodium 5000 UNT per 0.2 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978736dalteparin sodium 7500 UNT per 0.3 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978777dalteparin sodium 95,000 UNT in 3.8 ML Injectable SolutionSY23527b8b-9b28-4e6d-9751-33b143975ac727
978757Fragmin 10,000 UNT per 1 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
2618842Fragmin 10,000 UNT per 4 ML InjectionSY23527b8b-9b28-4e6d-9751-33b143975ac727
978741Fragmin 12,500 UNT per 0.5 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978745Fragmin 15,000 UNT per 0.6 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978747Fragmin 18,000 UNT per 0.72 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978727Fragmin 2500 UNT per 0.2 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978778Fragmin 25000 UNT/ML Injectable SolutionSY23527b8b-9b28-4e6d-9751-33b143975ac727
978735Fragmin 5000 UNT per 0.2 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978737Fragmin 7500 UNT per 0.3 ML Prefilled SyringeSY23527b8b-9b28-4e6d-9751-33b143975ac727
978778Fragmin 95,000 UNT in 3.8 ML Injectable SolutionSY23527b8b-9b28-4e6d-9751-33b143975ac727

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-0232-01000690232011 VIAL, MULTI-DOSE in 1 CARTON (0069-0232-01) / 3.8 mL in 1 VIAL, MULTI-DOSE2015-04-010000-00-00NoNoCurrent