NDC 0052-4330

Nexplanon

Etonogestrel

Nexplanon is a Subcutaneous Implant in the Human Prescription Drug category. It is labeled and distributed by Organon Usa Inc.. The primary component is Etonogestrel.

• Product ID: 0052-4330_14c63fee-00ce-4313-8806-b896cad93808
• NDC: 0052-4330
• Product Type: Human Prescription Drug
• Proprietary Name: Nexplanon
• Generic Name: Etonogestrel
• Dosage Form: Implant
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2013-09-27
• Marketing Category: NDA / NDA
• Application Number: NDA021529
• Labeler Name: Organon USA Inc.
• Substance Name: ETONOGESTREL
• Active Ingredient Strength: 68 mg/1
• Pharm Classes: Progesterone Congeners [CS],Progestin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0052-4330-01

1 BLISTER PACK in 1 CARTON (0052-4330-01) > 1 IMPLANT in 1 BLISTER PACK

• Marketing Start Date: 2013-09-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0052-4330-01 [00052433001]

Nexplanon IMPLANT

• Marketing Category: NDA
• Application Number: NDA021529
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-09-27

Drug Details

Active Ingredients

Ingredient	Strength
ETONOGESTREL	68 mg/1

OpenFDA Data

• SPL SET ID: b03a3917-9a65-45c2-bbbb-871da858ef34
• Manufacturer:
  • Organon USA Inc.
• UNII:
  • 304GTH6RNH
• RxNorm Concept Unique ID - RxCUI:
  • 1111011
  • 389221

Pharmacological Class

• Progesterone Congeners [CS]
• Progestin [EPC]

NDC Crossover Matching brand name "Nexplanon" or generic name "Etonogestrel"

NDC	Brand Name	Generic Name
0052-4330	Nexplanon	etonogestrel
78206-145	Nexplanon	etonogestrel
0052-0272	IMPLANON	etonogestrel