Hydrochlorothiazide

Product NDC
60429-215
11-digit product format
604290215
Labeler code
60429
Product ID
60429-215_7d002ab2-9e17-6500-e053-2a91aa0a6edb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc
Application
ANDA203018
Marketing category
ANDA
Marketing start
2014-07-23
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
50 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60429-215DDiscontinued by firm2026-07-31
excluded packagepackage60429-21560429-215-01DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203018-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2014-07-23
A203018-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2014-07-23

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A203018-001AB
A203018-002AB

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEScieGen Pharmaceuticals, Inc.02e96a51-1d56-460c-8c20-3d6f37e0ce462020-05-11Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS: Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Thiazides may add to or potentiate the action of other antihypertensive drugs. Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Lithium generally should not be given with diuretics (see PRECAUTIONS: Drug Interactions ). Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS: The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. Body as a Whole: Weakness. Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs). Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. Hypersensitivity: Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura. Metabolic: Electrolyte imbalance (see PRECAUTIONS ), hyperglycemia, glycosuria, hyperuricemia. Musculoskeletal: Muscle spasm. Nervous System/Psychiatric: Vertigo, paresthesias, dizziness, headache, restlessness. Renal: Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS ). Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia. Special Senses: Transient blurred vision, xanthopsia. Urogenital: Impotence. Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-215-01EA - Each60429-21565e73493-56d6-464e-98d1-6aebe5529fff12014-12-01
60429-215-10EA - Each60429-215b5eb02f4-5fd1-4bd2-9c5c-e711e877201312014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROCHLOROTHIAZIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCHLOROTHIAZIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCHLOROTHIAZIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]1