soltamox

Generic: tamoxifen citrate

Labeler: mayne pharma
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name soltamox
Generic Name tamoxifen citrate
Labeler mayne pharma
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

tamoxifen citrate 20 mg/10mL

Manufacturer
Mayne Pharma

Identifiers & Regulatory

Product NDC 51862-682
Product ID 51862-682_5bcbc281-342c-4b05-8409-53a08b1fc9f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021807
Listing Expiration 2026-12-31
Marketing Start 2021-06-18

Pharmacologic Class

Classes
estrogen agonist/antagonist [epc] selective estrogen receptor modulators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862682
Hyphenated Format 51862-682

Supplemental Identifiers

RxCUI
389230 644304
UNII
7FRV7310N6

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 soltamox (source: ndc)
Generic Name tamoxifen citrate (source: ndc)
Application Number NDA021807 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/10mL
source: ndc
Packaging
  • 1 CONTAINER in 1 CARTON (51862-682-00) / 150 mL in 1 CONTAINER
  • 1 CONTAINER in 1 CARTON (51862-682-01) / 150 mL in 1 CONTAINER
source: ndc

Packages (2)

51862-682-00 1 CONTAINER in 1 CARTON (51862-682-00) / 150 mL in 1 CONTAINER 51862-682-01 1 CONTAINER in 1 CARTON (51862-682-01) / 150 mL in 1 CONTAINER

Ingredients (1)

tamoxifen citrate (20 mg/10mL)

Linked Drug Pages (1)

SOLTAMOX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5bcbc281-342c-4b05-8409-53a08b1fc9f6", "openfda": {"unii": ["7FRV7310N6"], "rxcui": ["389230", "644304"], "spl_set_id": ["1e6ff055-590c-41e6-9530-1fdf04cdbd02"], "manufacturer_name": ["Mayne Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CONTAINER in 1 CARTON (51862-682-00)  / 150 mL in 1 CONTAINER", "package_ndc": "51862-682-00", "marketing_start_date": "20211206"}, {"sample": false, "description": "1 CONTAINER in 1 CARTON (51862-682-01)  / 150 mL in 1 CONTAINER", "package_ndc": "51862-682-01", "marketing_start_date": "20210618"}], "brand_name": "SOLTAMOX", "product_id": "51862-682_5bcbc281-342c-4b05-8409-53a08b1fc9f6", "dosage_form": "LIQUID", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "51862-682", "generic_name": "TAMOXIFEN CITRATE", "labeler_name": "Mayne Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOLTAMOX", "active_ingredients": [{"name": "TAMOXIFEN CITRATE", "strength": "20 mg/10mL"}], "application_number": "NDA021807", "marketing_category": "NDA", "marketing_start_date": "20210618", "listing_expiration_date": "20261231"}