FDA Orange Book · active-ingredient family
Digoxin
Digoxin: 4 brands, 16 generics; first approved Jul 26, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
16
Listed patents
0
Presentations
38
Brand (NDA) products
Originator applications
- DIGOXINRLDRSHIKMANDA 0216482004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML ELIXIR ORAL Rx AA - LANOXINRLDADVANZ PHARMANDA 02040519976 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.0625MG TABLET ORAL Rx AB 0.125MG TABLET ORAL Rx AB 0.1875MG TABLET ORAL Discontinued — 0.25MG TABLET ORAL Rx AB 0.375MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — - AZURITYNDA 009330—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/ML INJECTABLE INJECTION Rx AP 0.1MG/ML INJECTABLE INJECTION Rx — - GLAXOSMITHKLINE LLCNDA 01811819824 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG CAPSULE ORAL Discontinued — 0.05MG CAPSULE ORAL Discontinued — 0.1MG CAPSULE ORAL Discontinued — 0.15MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (16)
Abbreviated applications
- DIGOXINNOVITIUM PHARMAANDA 21530720223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG TABLET ORAL Rx AB 0.25MG TABLET ORAL Rx AB 0.0625MG TABLET ORAL Rx AB - DIGOXINAMICI PHARMAANDA 2152092022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML ELIXIR ORAL Rx AA - DIGOXINAUROBINDO PHARMA LTDANDA 21498220223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.0625MG TABLET ORAL Rx AB 0.125MG TABLET ORAL Rx AB 0.25MG TABLET ORAL Rx AB - DIGOXINVISTAPHARM LLCANDA 2130002019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML ELIXIR ORAL Rx AA - DIGOXINIMPAX LABSANDA 07855620092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG TABLET ORAL Discontinued — 0.25MG TABLET ORAL Discontinued — - DIGOXINHIKMA INTL PHARMSANDA 07700220072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Rx AB 0.125MG TABLET ORAL Rx AB - DIGOXINSANDOZANDA 0404812003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/ML INJECTABLE INJECTION Rx AP - DIGOXINSUN PHARM INDS INCANDA 07636320032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG TABLET ORAL Discontinued — 0.25MG TABLET ORAL Discontinued — - DIGOXINSTEVENS JANDA 07626820022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG TABLET ORAL Rx AB 0.25MG TABLET ORAL Rx AB - DIGOXINRISINGANDA 04028219992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.125MG TABLET ORAL Rx AB 0.25MG TABLET ORAL Rx AB - DIGOXINHOSPIRAANDA 0402061998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/ML INJECTABLE INJECTION Discontinued — - DIGOXINHOSPIRAANDA 0400931996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/ML INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 0400921996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/ML INJECTABLE INJECTION Discontinued — - DIGOXINABRAXIS PHARMANDA 083217—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/ML INJECTABLE INJECTION Discontinued — - DIGOXINHIKMAANDA 083391—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/ML INJECTABLE INJECTION Rx AP - DIGOXINWYETH AYERSTANDA 084386—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/ML INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
44 yr 9 mo ago
Most recent approval
4 yr 1 mo ago
Approvals span 1982–2022 across 20 FDA applications.
Brand (NDA) 420%
Generic (ANDA) 1680%
Digoxin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
