lanoxin
Generic: digoxin
Labeler: covis pharma us, incDrug Facts
Product Profile
Brand Name
lanoxin
Generic Name
digoxin
Labeler
covis pharma us, inc
Dosage Form
INJECTION, SOLUTION
Routes
Active Ingredients
digoxin 100 ug/mL
Manufacturer
Identifiers & Regulatory
Product NDC
70515-262
Product ID
70515-262_415f97e2-9ce0-b282-e063-6394a90ab0a8
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
NDA
Application Number
NDA009330
Listing Expiration
2026-12-31
Marketing Start
2017-09-15
Pharmacologic Class
Established (EPC)
Chemical Structure
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
70515262
Hyphenated Format
70515-262
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
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
lanoxin (source: ndc)
Generic Name
digoxin (source: ndc)
Application Number
NDA009330 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 100 ug/mL
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING LANOXIN (digoxin) Injection, 500 mcg/2 mL (250 mcg/mL); box of 10 single-dose ampules (NDC 70515 260 10) LANOXIN (digoxin) Injection, 500 mcg/2 mL (250 mcg/mL); box of 10 single-dose vials (NDC 70515 261 10) LANOXIN (digoxin) Injection Pediatric, 100 mcg/mL; box of 10 single-dose ampules (NDC 70515 262 10) LANOXIN (digoxin) Injection Pediatric, 100 mcg/mL; box of 10 single-dose vials (NDC 70515 263 10) Store at 25 °C (77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature] and protect from light. Discard unused portion.
- PRINCIPAL DISPLAY PANEL - Adult Carton Label - Ampule C O V I S 10 single-dose ampuls 2 mL each NDC 70515-260-10 Discard unused portion LANOXIN ® (digoxin) Injection 500 mcg/2 mL (250 mcg/mL) For intravenous or intramuscular injection. Dilution not required. In a vehicle of 42.5% (W/V) propylene glycol and 10% alcohol (V/V). Dibasic sodium phosphate 0.17%, citric acid anhydrous 0.08%. See prescribing information for dosage information. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] and protect from light. Manufactured for Covis Pharma Zug, 6300 Switzerland Made in Germany ©2024, Covis Pharma Rx only Principal Display Panel - Adult Carton Label - Ampule
- PRINCIPAL DISPLAY PANEL - Adult Carton Label - Vial C O V I S NDC 70515-261-10 10 single-dose vials 2 mL each Discard unused portion LANOXIN ® (digoxin) Injection 500 mcg/2 mL (250 mcg/mL) For Intravenous or Intramuscular Injection. Dilution not required. Rx only NDC 70515-261-10 LANOXIN ® (digoxin) Injection 500 mcg/2 mL (250 mcg/mL) In a vehicle of 42.5% (W/V) propylene glycol and 10% alcohol (V/V). Dibasic sodium phosphate 0.17%, citric acid anhydrous 0.08%. See prescribing information for dosage information. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] and protect from light. Manufactured for Covis Pharma Zug, 6300 Switzerland Made in Germany ©2024, Covis Pharma Principal Display Panel - Adult Carton Label - Vial
- PRINCIPAL DISPLAY PANEL - Pediatric Carton Label - Ampule NDC 70515-262-10 10 single-dose ampules 1 mL each – Discard unused portion LANOXIN ® (digoxin) Injection Pediatric 100 mcg/mL For intravenous or intramuscular injection. Dilution not required. In a vehicle of 42.5% (W/V) propylene glycol and 10% alcohol (V/V). Sodium phosphate 0.17%. Citric acid anhydrous 0.08%. See prescribing information for dosage information. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] and protect from light. Rx only C O V I S Principal Display Panel - Pediatric Carton Label - Ampule
- PRINCIPAL DISPLAY PANEL - Pediatric Carton Label - Vial NDC 70515-263-10 10 vials 1 mL each – Discard unused portion Rx only LANOXIN ® (digoxin) Injection Pediatric 100 mcg/mL For Intravenous or Intramuscular Injection. Dilution not required. C O V I S NDC 70515-263-10 10 single-dose vials 1 mL each LANOXIN ® (digoxin) Injection Pediatric 100 mcg/mL In a vehicle of 42.5% (W/V) propylene glycol and 10% alcohol (V/V). Sodium phosphate 0.17%. Citric acid anhydrous 0.08%. See prescribing information for dosage information. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] and protect from light. Manufactured for Covis Pharma Zug, 6300 Switzerland Made in Germany ©2024, Covis Pharma Principal Display Panel - Pediatric Carton Label - Vial
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "415f97e2-9ce0-b282-e063-6394a90ab0a8", "openfda": {"nui": ["N0000175568", "M0003451"], "unii": ["73K4184T59"], "rxcui": ["104208", "204504", "208135", "208137"], "spl_set_id": ["9ec84cac-6ecc-43dc-8006-6ccc029e2707"], "pharm_class_cs": ["Cardiac Glycosides [CS]"], "pharm_class_epc": ["Cardiac Glycoside [EPC]"], "manufacturer_name": ["Covis Pharma US, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "LANOXIN", "product_id": "70515-262_415f97e2-9ce0-b282-e063-6394a90ab0a8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Cardiac Glycoside [EPC]", "Cardiac Glycosides [CS]"], "product_ndc": "70515-262", "generic_name": "digoxin", "labeler_name": "Covis Pharma US, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LANOXIN", "active_ingredients": [{"name": "DIGOXIN", "strength": "100 ug/mL"}], "application_number": "NDA009330", "marketing_category": "NDA", "marketing_start_date": "20170915", "listing_expiration_date": "20261231"}