NDC 69452-243

BionaFem

Levonorgestrel

BionaFem is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Bionpharma Inc.. The primary component is Levonorgestrel.

• Product ID: 69452-243_1a5852b7-0cfc-47f0-8948-de298f91ce02
• NDC: 69452-243
• Product Type: Human Otc Drug
• Proprietary Name: BionaFem
• Generic Name: Levonorgestrel
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207044
• Labeler Name: Bionpharma Inc.
• Substance Name: LEVONORGESTREL
• Active Ingredient Strength: 2 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69452-243-60

1 BLISTER PACK in 1 CARTON (69452-243-60) > 1 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2019-04-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69452-243-60 [69452024360]

BionaFem TABLET

• Marketing Category: ANDA
• Application Number: ANDA207044
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-04-14

Drug Details

Active Ingredients

Ingredient	Strength
LEVONORGESTREL	1.5 mg/1

OpenFDA Data

• SPL SET ID: b5eb3717-c2ab-4279-bce9-e3559c69e2bb
• Manufacturer:
  • Bionpharma Inc.
• UNII:
  • 5W7SIA7YZW

NDC Crossover Matching brand name "BionaFem" or generic name "Levonorgestrel"

NDC	Brand Name	Generic Name
69452-243	BionaFem	BionaFem
50102-111	EContra EZ	levonorgestrel
50102-211	EContra One-Step	Levonorgestrel
50419-424	Kyleena	Levonorgestrel
0536-1142	Levonorgestrel	Levonorgestrel
40032-620	Levonorgestrel	Levonorgestrel
40032-622	Levonorgestrel	Levonorgestrel
40051-054	LEVONORGESTREL	levonorgestrel
49615-017	Levonorgestrel	Levonorgestrel
0023-5858	LILETTA	Levonorgestrel
50419-423	Mirena	Levonorgestrel
43386-620	My Way	Levonorgestrel
43386-622	My Way	Levonorgestrel
16714-809	New Day	levonorgestrel
21695-443	NEXT CHOICE	Levonorgestrel
0113-2003	Option 2	levonorgestrel
21695-973	Plan B One-Step	levonorgestrel
50090-1141	Plan B One-Step	Levonorgestrel
50090-3830	Plan B One-Step	levonorgestrel
50090-5978	Plan B One-Step	levonorgestrel
11509-0067	Preventeza	levonorgestrel
50419-422	Skyla	Levonorgestrel