Home NDC 0115-9811 Digoxin
Product NDC 0115-9811
11-digit product format 001159811
Labeler code 0115
Product ID 0115-9811_606fde89-1d1f-43b4-a06b-aaa36b994315
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DIGOXIN
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA078556
Marketing category ANDA
Marketing start 2009-07-20
Substance DIGOXIN
Active strength 125 ug/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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078556-001 DIGOXIN DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 A078556-002 DIGOXIN DIGOXIN 0.25MG TABLET / ORAL 2009-07-20
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 3 · 84 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 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Digoxin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIGOXIN 125 ug/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 197606 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 0115-9811-01 Digoxin 100 in 1 BOTTLE TABLET 100 18 0115-9811-02 Digoxin 500 in 1 BOTTLE TABLET 500 18 0115-9811-03 Digoxin 1000 in 1 BOTTLE TABLET 1000 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIGOXIN ACTIVE INGREDIENT 73K4184T59 DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 8 DIGOXIN ACTIVE MOIETY 73K4184T59 DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 8 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIGOXIN TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 8 DIGOXIN ACTIVE INGREDIENT 73K4184T59 DIGOXIN TABLET [AMERICAN HEALTH PACKAGING] 1 DIGOXIN ACTIVE MOIETY 73K4184T59 DIGOXIN TABLET [AMERICAN HEALTH PACKAGING] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIGOXIN TABLET [AMERICAN HEALTH PACKAGING] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M DIGOXIN TABLET [AMERICAN HEALTH PACKAGING] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DIGOXIN TABLET [AMERICAN HEALTH PACKAGING] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIGOXIN TABLET [AMERICAN HEALTH PACKAGING] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIGOXIN TABLET [AMERICAN HEALTH PACKAGING] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-9811 DIGOXIN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 18 Current NDC, Legacy NDC, 3 package rows 20240906_dfac7f13-28be-423d-9389-9089da29da17.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 · 1 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 0115-9811-01 00115981101 100 TABLET in 1 BOTTLE (0115-9811-01) 100 tablet 2009-07-20 0000-00-00 No No Current 0115-9811-02 00115981102 500 TABLET in 1 BOTTLE (0115-9811-02) 500 tablet 2009-07-20 0000-00-00 No No Current 0115-9811-03 00115981103 1000 TABLET in 1 BOTTLE (0115-9811-03) 1000 tablet 2009-07-20 0000-00-00 No No Current