Home NDC 49884-514 DIGOXIN
Product NDC 49884-514
11-digit product format 498840514
Labeler code 49884
Product ID 49884-514_86c8d078-9090-4b77-adc6-49abfcdd74dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DIGOXIN
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical Inc.
Application NDA020405
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-01-14
Marketing end 2021-02-28
Substance DIGOXIN
Active strength 0 mg/1
Pharmacologic classes Cardiac Glycoside [EPC],Cardiac Glycosides [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIGOXIN ACTIVE INGREDIENT 73K4184T59 DIGOXIN TABLET [PAR PHARMACEUTICAL, INC] 1 DIGOXIN ACTIVE INGREDIENT 73K4184T59 DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 DIGOXIN ACTIVE MOIETY 73K4184T59 DIGOXIN TABLET [PAR PHARMACEUTICAL, INC] 1 DIGOXIN ACTIVE MOIETY 73K4184T59 DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DIGOXIN TABLET [PAR PHARMACEUTICAL, INC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DIGOXIN TABLET [PAR PHARMACEUTICAL, INC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DIGOXIN TABLET [PAR PHARMACEUTICAL, INC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIGOXIN TABLET [PAR PHARMACEUTICAL, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIGOXIN TABLET [PAR PHARMACEUTICAL, INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T DIGOXIN TABLET [PAR PHARMACEUTICAL, INC] 1 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
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 49884-514-01 49884051401 100 TABLET in 1 BOTTLE (49884-514-01) 100 tablet 2014-01-14 2021-02-28 No No Current 49884-514-10 49884051410 1000 TABLET in 1 BOTTLE (49884-514-10) 1000 tablet 2014-01-14 2021-02-28 No No Current