NDC 57297-853

Fallback Solo

Levonorgestrel

Fallback Solo is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Lupin Limited. The primary component is Levonorgestrel.

• Product ID: 57297-853_5779cd78-b5b7-43fe-a866-bd2f2533f70b
• NDC: 57297-853
• Product Type: Human Otc Drug
• Proprietary Name: Fallback Solo
• Generic Name: Levonorgestrel
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-07-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201446
• Labeler Name: LUPIN LIMITED
• Substance Name: LEVONORGESTREL
• Active Ingredient Strength: 2 mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 57297-853-13

1 BLISTER PACK in 1 CARTON (57297-853-13) > 1 TABLET in 1 BLISTER PACK (57297-853-11)

• Marketing Start Date: 2014-07-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57297-853-11 [57297085311]

Fallback Solo TABLET

• Marketing Category: ANDA
• Application Number: ANDA201446
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-07-22

NDC 57297-853-13 [57297085313]

Fallback Solo TABLET

• Marketing Category: ANDA
• Application Number: ANDA201446
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-07-22
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
LEVONORGESTREL	1.5 mg/1

OpenFDA Data

• SPL SET ID: b2d5d0c2-f10a-4c39-af03-17a87fc4bd9d
• Manufacturer:
  • LUPIN LIMITED
• UNII:
  • 5W7SIA7YZW
• RxNorm Concept Unique ID - RxCUI:
  • 483325
  • 1543735

NDC Crossover Matching brand name "Fallback Solo" or generic name "Levonorgestrel"

NDC	Brand Name	Generic Name
68180-853	Fallback Solo	Fallback Solo
57297-853	Fallback Solo	Fallback Solo
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