levonorgestrel

Generic: levonorgestrel

Labeler: xiromed llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levonorgestrel
Generic Name levonorgestrel
Labeler xiromed llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer
Xiromed LLC

Identifiers & Regulatory

Product NDC 70700-164
Product ID 70700-164_6ccbcf9e-fe8a-a97f-06f9-a4e4726d919c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA205329
Listing Expiration 2026-12-31
Marketing Start 2020-03-13

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 70700164
Hyphenated Format 70700-164

Supplemental Identifiers

RxCUI
483325
UPC
0370700164068
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 ANDA205329 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (70700-164-06) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

70700-164-06 1 BLISTER PACK in 1 CARTON (70700-164-06) / 1 TABLET in 1 BLISTER PACK

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": "6ccbcf9e-fe8a-a97f-06f9-a4e4726d919c", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "upc": ["0370700164068"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325"], "spl_set_id": ["626a2333-ff56-ef28-a287-b33bacc0302a"], "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": ["Xiromed LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70700-164-06)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "70700-164-06", "marketing_start_date": "20200313"}], "brand_name": "Levonorgestrel", "product_id": "70700-164_6ccbcf9e-fe8a-a97f-06f9-a4e4726d919c", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "70700-164", "generic_name": "Levonorgestrel", "labeler_name": "Xiromed LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Levonorgestrel", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA205329", "marketing_category": "ANDA", "marketing_start_date": "20200313", "listing_expiration_date": "20261231"}