new day

Generic: levonorgestrel

Labeler: northstar rx llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name new day
Generic Name levonorgestrel
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 16714-809
Product ID 16714-809_c8098a08-68ab-4487-9db1-aefc6322ed30
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207976
Listing Expiration 2026-12-31
Marketing Start 2016-03-11

Pharmacologic Class

Established (EPC)
progestin [epc] progestin-containing intrauterine system [epc]
Chemical Structure
progesterone congeners [cs]
Physiologic Effect
inhibit ovum fertilization [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714809
Hyphenated Format 16714-809

Supplemental Identifiers

RxCUI
483325 2003710
UNII
5W7SIA7YZW
NUI
N0000175830 M0447349 N0000175602 N0000175832

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 new day (source: ndc)
Generic Name levonorgestrel (source: ndc)
Application Number ANDA207976 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (16714-809-01) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

16714-809-01 1 BLISTER PACK in 1 CARTON (16714-809-01) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

New Day ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c8098a08-68ab-4487-9db1-aefc6322ed30", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325", "2003710"], "spl_set_id": ["9e8c96f6-ab51-4721-b276-1ca02a712510"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_pe": ["Inhibit Ovum Fertilization [PE]"], "pharm_class_epc": ["Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (16714-809-01)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "16714-809-01", "marketing_start_date": "20160311"}], "brand_name": "New Day", "product_id": "16714-809_c8098a08-68ab-4487-9db1-aefc6322ed30", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "16714-809", "generic_name": "levonorgestrel", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "New Day", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA207976", "marketing_category": "ANDA", "marketing_start_date": "20160311", "listing_expiration_date": "20261231"}