nexplanon

Generic: etonogestrel

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nexplanon
Generic Name etonogestrel
Labeler organon llc
Dosage Form IMPLANT
Routes
SUBCUTANEOUS
Active Ingredients

etonogestrel 68 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-145
Product ID 78206-145_11bdb463-b672-4e94-993d-bd1b22dc6654
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021529
Listing Expiration 2027-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Established (EPC)
progestin [epc]
Chemical Structure
progesterone congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206145
Hyphenated Format 78206-145

Supplemental Identifiers

RxCUI
389221 1111011
UNII
304GTH6RNH
NUI
M0447349 N0000175602

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nexplanon (source: ndc)
Generic Name etonogestrel (source: ndc)
Application Number NDA021529 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 68 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (78206-145-01) / 1 IMPLANT in 1 BLISTER PACK
source: ndc

Packages (1)

78206-145-01 1 BLISTER PACK in 1 CARTON (78206-145-01) / 1 IMPLANT in 1 BLISTER PACK

Ingredients (1)

etonogestrel (68 mg/1)

Linked Drug Pages (1)

Nexplanon ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "11bdb463-b672-4e94-993d-bd1b22dc6654", "openfda": {"nui": ["M0447349", "N0000175602"], "unii": ["304GTH6RNH"], "rxcui": ["389221", "1111011"], "spl_set_id": ["487f8a62-e142-457c-97cc-2e398fde7594"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (78206-145-01)  / 1 IMPLANT in 1 BLISTER PACK", "package_ndc": "78206-145-01", "marketing_start_date": "20210601"}], "brand_name": "Nexplanon", "product_id": "78206-145_11bdb463-b672-4e94-993d-bd1b22dc6654", "dosage_form": "IMPLANT", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "78206-145", "generic_name": "etonogestrel", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nexplanon", "active_ingredients": [{"name": "ETONOGESTREL", "strength": "68 mg/1"}], "application_number": "NDA021529", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20271231"}