camila

Generic: norethindrone

Labeler: mayne pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name camila
Generic Name norethindrone
Labeler mayne pharma inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone .35 mg/1

Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 51862-884
Product ID 51862-884_022c6de4-4589-4d4c-8ac4-977c7e3ef568
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076177
Listing Expiration 2026-12-31
Marketing Start 2018-06-15

Pharmacologic Class

Established (EPC)
progestin [epc]
Chemical Structure
progesterone congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862884
Hyphenated Format 51862-884

Supplemental Identifiers

RxCUI
198042 748961 748962
UNII
T18F433X4S
NUI
M0447349 N0000175602

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 camila (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA076177 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (51862-884-03) / 28 TABLET in 1 BLISTER PACK (51862-884-01)
source: ndc

Packages (1)

51862-884-03 3 BLISTER PACK in 1 CARTON (51862-884-03) / 28 TABLET in 1 BLISTER PACK (51862-884-01)

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

CAMILA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "022c6de4-4589-4d4c-8ac4-977c7e3ef568", "openfda": {"nui": ["M0447349", "N0000175602"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961", "748962"], "spl_set_id": ["a786be85-49ba-4369-b510-7dccc10f7f18"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (51862-884-03)  / 28 TABLET in 1 BLISTER PACK (51862-884-01)", "package_ndc": "51862-884-03", "marketing_start_date": "20180615"}], "brand_name": "CAMILA", "product_id": "51862-884_022c6de4-4589-4d4c-8ac4-977c7e3ef568", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "51862-884", "generic_name": "NORETHINDRONE", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CAMILA", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA076177", "marketing_category": "ANDA", "marketing_start_date": "20180615", "listing_expiration_date": "20261231"}