FDA Orange Book · active-ingredient family
Betamethasone valerate
Betamethasone valerate: 15 brands, 18 generics; first approved Mar 24, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Brands (NDA)
15
Generics (ANDA)
18
Listed patents
0
Presentations
34
Brand (NDA) products
Originator applications
- LUXIQRLDPHARMOBEDIENTNDA 0209341999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.12% AEROSOL, FOAM TOPICAL Discontinued — - BETAMETHASONE VALERATERLDRSFOUGERA PHARMS INCNDA 0188611983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE CREAM TOPICAL Rx AB - BETAMETHASONE VALERATERLDRSFOUGERA PHARMS INCNDA 0188661983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE LOTION TOPICAL Rx AB - BETAMETHASONE VALERATERLDRSFOUGERA PHARMS INCNDA 0188651983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE OINTMENT TOPICAL Rx AB - BETAMETHASONE VALERATEPHARMADERMNDA 0188601983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE CREAM TOPICAL Discontinued — - SAVAGE LABSNDA 0188621983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE CREAM TOPICAL Discontinued — - BETAMETHASONE VALERATEPHARMADERMNDA 0188701983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE LOTION TOPICAL Discontinued — - SAVAGE LABSNDA 0188671983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE LOTION TOPICAL Discontinued — - BETAMETHASONE VALERATEPHARMADERMNDA 0188641983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE OINTMENT TOPICAL Discontinued — - SAVAGE LABSNDA 0188631983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE OINTMENT TOPICAL Discontinued — - ROACONDA 0188391983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE CREAM TOPICAL Discontinued — - COSETTE PHARMS NCNDA 0186421983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE CREAM TOPICAL Rx AB - SCHERINGNDA 016322—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE CREAM TOPICAL Discontinued — EQ 0.01% BASE CREAM TOPICAL Discontinued — - SCHERINGNDA 016932—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE LOTION TOPICAL Discontinued — - SCHERINGNDA 016740—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE OINTMENT TOPICAL Discontinued —
Generic (ANDA) products (18)
Abbreviated applications
- BETAMETHASONE VALERATEALEMBICANDA 2158322024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.12% AEROSOL, FOAM TOPICAL Rx AB - BETAMETHASONE VALERATEXIROMEDANDA 2106392023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.12% AEROSOL, FOAM TOPICAL Rx AB - BETAMETHASONE VALERATEINGENUS PHARMS LLCANDA 2071442017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.12% AEROSOL, FOAM TOPICAL Discontinued — - BETAMETHASONE VALERATERSTAROANDA 2082042017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.12% AEROSOL, FOAM TOPICAL Rx AB - BETAMETHASONE VALERATEPADAGIS ISRAELANDA 0783372012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.12% AEROSOL, FOAM TOPICAL Rx AB - BETAMETHASONE VALERATETEVA PHARMSANDA 0718831988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE LOTION TOPICAL Discontinued — - SUN PHARMA CANADAANDA 0720411988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE CREAM TOPICAL Rx AB - BETAMETHASONE VALERATEPERRIGO NEW YORKANDA 0714781987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE OINTMENT TOPICAL Discontinued — - BETAMETHASONE VALERATEPHARMAFAIRANDA 0704851987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE CREAM TOPICAL Discontinued — - BETAMETHASONE VALERATEPHARMAFAIRANDA 0704841987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE LOTION TOPICAL Discontinued — - BETAMETHASONE VALERATEPHARMAFAIRANDA 0704861987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE OINTMENT TOPICAL Discontinued — - BETAMETHASONE VALERATEPERRIGO NEW YORKANDA 0700531986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE CREAM TOPICAL Discontinued — - COSETTE PHARMS NCANDA 0700691985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE OINTMENT TOPICAL Rx AB - BETAMETHASONE VALERATESENORES PHARMSANDA 0700521985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE LOTION TOPICAL Rx AB - COSETTE PHARMS NCANDA 0700721985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE LOTION TOPICAL Discontinued — - BETAMETHASONE VALERATESUN PHARMA CANADAANDA 0700621985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE CREAM TOPICAL Discontinued — - ACTAVIS MID ATLANTICANDA 0700501984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE CREAM TOPICAL Rx AB - BETAMETHASONE VALERATEACTAVIS MID ATLANTICANDA 0700511984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1% BASE OINTMENT TOPICAL Rx AB
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 ago
Most recent approval
2 yr ago
Approvals span 1983–2024 across 33 FDA applications.
Brand (NDA) 1545%
Generic (ANDA) 1855%
Betamethasone valerate: 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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.
