Orange Book product · Brand (NDA)
MICROZIDE
HYDROCHLOROTHIAZIDE
At a glance
Dec 27, 1996
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 27, 1996
29 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCHLOROTHIAZIDE
Strength
12.5MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 020504
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025INZIRQOBrand (NDA)
NDA 219141 · NOVITIUM PHARMA
- —ESIDRIXBrand (NDA)
NDA 011793 · NOVARTIS
- 2024HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 083177 · IVAX SUB TEVA PHARMS
- 2023HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 085182 · HERITAGE
- 2019HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 203561 · SCIEGEN PHARMS
- 2014HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 090651 · SUN PHARM INDS INC
- 2012HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 202556 · ACCORD HLTHCARE
- 2012HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 091662 · CHARTWELL MOLECULAR
- 2010HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 200645 · ALEMBIC PHARMS LTD
- 2010HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 090510 · UNICHEM
- 2009HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 079237 · IPCA LABS LTD
- 2008HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 078389 · APOTEX
Listed patents
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.
