HYDROCHLOROTHIAZIDE

Product NDC
23155-008
11-digit product format
231550008
Labeler code
23155
Product ID
23155-008_a1057270-4261-4cac-bc26-2dbffb13eacb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA085182
Marketing category
ANDA
Marketing start
2015-01-15
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085182-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982
A085182-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982
A085182-003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A085182-001AB
A085182-002AB
A085182-003AB

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
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.c59c4230-7cea-4259-9f2f-6a568716fedf2025-06-02Warnings, 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 imparied 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. Musculosketetal: 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. Postmarketing Experience Non-melanoma Skin Cancer Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year. Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTION, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROCHLOROTHIAZIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH
Rxcui197770, 310798, 429503

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-008-01HYDROCHLOROTHIAZIDE100 in 1 BOTTLETABLET10012
23155-008-05HYDROCHLOROTHIAZIDE500 in 1 BOTTLETABLET50012
23155-008-10HYDROCHLOROTHIAZIDE1000 in 1 BOTTLETABLET100012
23155-008-18HYDROCHLOROTHIAZIDE5000 in 1 BOTTLETABLET500012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-008-01EA - Each23155-008545d68a3-e0a7-4d25-b007-7a20c6bfc63f12015-04-03
23155-008-10EA - Each23155-008dcb4f749-398e-431a-a23e-b7b2a8bd30ca12015-04-03
23155-008-18EA - Each23155-008df55f6c0-25b1-4fa2-b24e-0f92d932b16612015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-008HYDROCHLOROTHIAZIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 4 package rows20230504_c59c4230-7cea-4259-9f2f-6a568716fedf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSNc59c4230-7cea-4259-9f2f-6a568716fedf12
310798hydroCHLOROthiazide 25 MG Oral TabletPSNc59c4230-7cea-4259-9f2f-6a568716fedf12
197770hydroCHLOROthiazide 50 MG Oral TabletPSNc59c4230-7cea-4259-9f2f-6a568716fedf12
429503hydrochlorothiazide 12.5 MG Oral TabletSCDc59c4230-7cea-4259-9f2f-6a568716fedf12
310798hydrochlorothiazide 25 MG Oral TabletSCDc59c4230-7cea-4259-9f2f-6a568716fedf12
197770hydrochlorothiazide 50 MG Oral TabletSCDc59c4230-7cea-4259-9f2f-6a568716fedf12
429503HCTZ 12.5 MG Oral TabletSYc59c4230-7cea-4259-9f2f-6a568716fedf12
310798HCTZ 25 MG Oral TabletSYc59c4230-7cea-4259-9f2f-6a568716fedf12
197770HCTZ 50 MG Oral TabletSYc59c4230-7cea-4259-9f2f-6a568716fedf12
310798hydroCHLOROthiazide 25 MG Oral TabletPSNdb1213f0-a981-4d30-86b3-372e4dadc7349
310798hydrochlorothiazide 25 MG Oral TabletSCDdb1213f0-a981-4d30-86b3-372e4dadc7349
310798HCTZ 25 MG Oral TabletSYdb1213f0-a981-4d30-86b3-372e4dadc7349
310798hydroCHLOROthiazide 25 MG Oral TabletPSNc8c79657-a09a-bdb6-e053-2995a90ab6734
310798hydroCHLOROthiazide 25 MG Oral TabletPSNf795db5e-d5ef-4a20-e053-6394a90a7fda4
310798hydrochlorothiazide 25 MG Oral TabletSCDc8c79657-a09a-bdb6-e053-2995a90ab6734
310798hydrochlorothiazide 25 MG Oral TabletSCDf795db5e-d5ef-4a20-e053-6394a90a7fda4
310798HCTZ 25 MG Oral TabletSYc8c79657-a09a-bdb6-e053-2995a90ab6734
310798HCTZ 25 MG Oral TabletSYf795db5e-d5ef-4a20-e053-6394a90a7fda4
310798hydroCHLOROthiazide 25 MG Oral TabletPSNa111cb8f-a100-a05d-e053-2995a90a020c3
310798hydroCHLOROthiazide 25 MG Oral TabletPSN31a3d1cb-0f52-4818-965d-7584374bb23e3
310798hydrochlorothiazide 25 MG Oral TabletSCDa111cb8f-a100-a05d-e053-2995a90a020c3
310798hydrochlorothiazide 25 MG Oral TabletSCD31a3d1cb-0f52-4818-965d-7584374bb23e3
310798HCTZ 25 MG Oral TabletSYa111cb8f-a100-a05d-e053-2995a90a020c3
310798HCTZ 25 MG Oral TabletSY31a3d1cb-0f52-4818-965d-7584374bb23e3
310798hydroCHLOROthiazide 25 MG Oral TabletPSN5605f105-f7ec-473f-8beb-9e8955e8e26e2
310798hydrochlorothiazide 25 MG Oral TabletSCD5605f105-f7ec-473f-8beb-9e8955e8e26e2
310798HCTZ 25 MG Oral TabletSY5605f105-f7ec-473f-8beb-9e8955e8e26e2
310798hydroCHLOROthiazide 25 MG Oral TabletPSN3464be28-5bab-4642-9d9b-8b425822dd071
310798hydrochlorothiazide 25 MG Oral TabletSCD3464be28-5bab-4642-9d9b-8b425822dd071
310798HCTZ 25 MG Oral TabletSY3464be28-5bab-4642-9d9b-8b425822dd071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-008-0123155000801100 TABLET in 1 BOTTLE (23155-008-01) 100 tablet2015-01-150000-00-00NoNoCurrent
23155-008-0523155000805500 TABLET in 1 BOTTLE (23155-008-05) 500 tablet2015-01-150000-00-00NoNoCurrent
23155-008-10231550008101000 TABLET in 1 BOTTLE (23155-008-10) 1000 tablet2015-01-150000-00-00NoNoCurrent
23155-008-18231550008185000 TABLET in 1 BOTTLE (23155-008-18) 5000 tablet2015-02-010000-00-00NoNoCurrent