Home NDC 71610-019 LANOXIN
Product NDC 71610-019
11-digit product format 716100019
Labeler code 71610
Product ID 71610-019_1d7755ac-5480-4614-bc20-beb024ab95f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name digoxin
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA020405
Marketing category NDA
Marketing start 2012-09-30
Substance DIGOXIN
Active strength .125 mg/1
Pharmacologic classes Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020405-001 LANOXIN DIGOXIN 0.0625MG TABLET / ORAL AB RLD 1997-09-30 N020405-002 LANOXIN DIGOXIN 0.125MG TABLET / ORAL AB RLD 1997-09-30 N020405-003 LANOXIN DIGOXIN 0.1875MG TABLET / ORAL RLD 1997-09-30 N020405-004 LANOXIN DIGOXIN 0.25MG TABLET / ORAL AB RLD, RS 1997-09-30 N020405-005 LANOXIN DIGOXIN 0.375MG TABLET / ORAL 1997-09-30 N020405-006 LANOXIN DIGOXIN 0.5MG TABLET / ORAL 1997-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 7 · 252 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020405-001 LANOXIN 0.0625MG TABLET / ORAL AB RLD 1997-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020405-002 LANOXIN 0.125MG TABLET / ORAL AB RLD 1997-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020405-003 LANOXIN 0.1875MG TABLET / ORAL RLD 1997-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020405-004 LANOXIN 0.25MG TABLET / ORAL AB RLD, RS 1997-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020405-005 LANOXIN 0.375MG TABLET / ORAL 1997-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020405-006 LANOXIN 0.5MG TABLET / ORAL 1997-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020405-001 LANOXIN 0.0625MG TABLET / ORAL AB RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020405-002 LANOXIN 0.125MG TABLET / ORAL AB RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020405-003 LANOXIN 0.1875MG TABLET / ORAL RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020405-004 LANOXIN 0.25MG TABLET / ORAL AB RLD, RS 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020405-005 LANOXIN 0.375MG TABLET / ORAL 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020405-006 LANOXIN 0.5MG TABLET / ORAL 1997-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020405-001 LANOXIN 0.0625MG TABLET / ORAL AB RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020405-002 LANOXIN 0.125MG TABLET / ORAL AB RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020405-003 LANOXIN 0.1875MG TABLET / ORAL RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020405-004 LANOXIN 0.25MG TABLET / ORAL AB RLD, RS 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020405-005 LANOXIN 0.375MG TABLET / ORAL 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020405-006 LANOXIN 0.5MG TABLET / ORAL 1997-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020405-001 LANOXIN 0.0625MG TABLET / ORAL AB RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020405-002 LANOXIN 0.125MG TABLET / ORAL AB RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020405-003 LANOXIN 0.1875MG TABLET / ORAL RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020405-004 LANOXIN 0.25MG TABLET / ORAL AB RLD, RS 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020405-005 LANOXIN 0.375MG TABLET / ORAL 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020405-006 LANOXIN 0.5MG TABLET / ORAL 1997-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020405-001 LANOXIN 0.0625MG TABLET / ORAL AB RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020405-002 LANOXIN 0.125MG TABLET / ORAL AB RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020405-003 LANOXIN 0.1875MG TABLET / ORAL RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020405-004 LANOXIN 0.25MG TABLET / ORAL AB RLD, RS 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020405-005 LANOXIN 0.375MG TABLET / ORAL 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020405-006 LANOXIN 0.5MG TABLET / ORAL 1997-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020405-001 LANOXIN 0.0625MG TABLET / ORAL AB RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020405-002 LANOXIN 0.125MG TABLET / ORAL AB RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020405-003 LANOXIN 0.1875MG TABLET / ORAL RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020405-004 LANOXIN 0.25MG TABLET / ORAL AB RLD, RS 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020405-005 LANOXIN 0.375MG TABLET / ORAL 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020405-006 LANOXIN 0.5MG TABLET / ORAL 1997-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020405-001 LANOXIN 0.0625MG TABLET / ORAL AB RLD 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020405-002 LANOXIN 0.125MG TABLET / ORAL AB RLD 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020405-003 LANOXIN 0.1875MG TABLET / ORAL RLD 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020405-004 LANOXIN 0.25MG TABLET / ORAL AB RLD, RS 1997-09-30 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 observed states.
Additional Listing Data#
Finished product Yes
Brand name base LANOXIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIGOXIN .125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 73K4184T59 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197604 Internal RxNorm lookup 309888 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-019-60 LANOXIN 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-019 LANOXIN (DIGOXIN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20190515_f6c7ca21-1c76-4838-8fb9-e1bec6001d8b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71610-019-60 71610001960 90 TABLET in 1 BOTTLE (71610-019-60) 90 tablet 2017-12-08 0000-00-00 No No Current