NDC 0069-0196

Fragmin

Dalteparin Sodium

Fragmin is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Dalteparin Sodium.

• Product ID: 0069-0196_16bbab6a-76a5-4a0f-b68c-deacd61a8ab4
• NDC: 0069-0196
• Product Type: Human Prescription Drug
• Proprietary Name: Fragmin
• Generic Name: Dalteparin Sodium
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2015-04-01
• Marketing Category: NDA / NDA
• Application Number: NDA020287
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: DALTEPARIN SODIUM
• Active Ingredient Strength: 5000 [iU]/.2mL
• Pharm Classes: Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [CS],Low Molecular Weight Heparin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0069-0196-02

10 SYRINGE in 1 CARTON (0069-0196-02) > .2 mL in 1 SYRINGE (0069-0196-01)

• Marketing Start Date: 2015-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0196-02 [00069019602]

Fragmin INJECTION

• Marketing Category: NDA
• Application Number: NDA020287
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-04-01

NDC 0069-0196-01 [00069019601]

Fragmin INJECTION

• Marketing Category: NDA
• Application Number: NDA020287
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-06-11

Drug Details

Active Ingredients

Ingredient	Strength
DALTEPARIN SODIUM	5000 [iU]/.2mL

OpenFDA Data

• SPL SET ID: 23527b8b-9b28-4e6d-9751-33b143975ac7
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • 12M44VTJ7B
• RxNorm Concept Unique ID - RxCUI:
  • 978741
  • 978755
  • 978733
  • 978735
  • 978736
  • 978737
  • 978727
  • 978740
  • 978725
  • 978745
  • 978744
  • 978747
  • 978746
  • 978778
  • 978777
  • 978757

Pharmacological Class

• Anti-coagulant [EPC]
• Heparin
• Low-Molecular-Weight [CS]
• Low Molecular Weight Heparin [EPC]

NDC Crossover Matching brand name "Fragmin" or generic name "Dalteparin Sodium"

NDC	Brand Name	Generic Name
0069-0195	Fragmin	Dalteparin Sodium
0069-0196	Fragmin	Dalteparin Sodium
0069-0206	Fragmin	Dalteparin Sodium
0069-0217	Fragmin	Dalteparin Sodium
0069-0220	Fragmin	Dalteparin Sodium
0069-0223	Fragmin	Fragmin
0069-0228	Fragmin	Fragmin
0069-0232	Fragmin	Fragmin