levonorgestrel

Generic: levonorgestrel

Labeler: novel laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levonorgestrel
Generic Name levonorgestrel
Labeler novel laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer
Novel Laboratories, Inc.

Identifiers & Regulatory

Product NDC 40032-622
Product ID 40032-622_af913ba6-b143-43c5-86fc-a36fd494b29d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202508
Listing Expiration 2026-12-31
Marketing Start 2013-02-15

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 40032622
Hyphenated Format 40032-622

Supplemental Identifiers

RxCUI
483325
UPC
0340032622307
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 levonorgestrel (source: ndc)
Generic Name levonorgestrel (source: ndc)
Application Number ANDA202508 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 1 TABLET in 1 CARTON (40032-622-30)
source: ndc

Packages (1)

40032-622-30 1 TABLET in 1 CARTON (40032-622-30)

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

Levonorgestrel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "af913ba6-b143-43c5-86fc-a36fd494b29d", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "upc": ["0340032622307"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325"], "spl_set_id": ["ac13a073-a33a-45f7-8483-eecc9190195f"], "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": ["Novel Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET in 1 CARTON (40032-622-30)", "package_ndc": "40032-622-30", "marketing_start_date": "20130215"}], "brand_name": "Levonorgestrel", "product_id": "40032-622_af913ba6-b143-43c5-86fc-a36fd494b29d", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine Device [EPC]"], "product_ndc": "40032-622", "generic_name": "Levonorgestrel", "labeler_name": "Novel Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levonorgestrel", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA202508", "marketing_category": "ANDA", "marketing_start_date": "20130215", "listing_expiration_date": "20261231"}