Hydrochlorothiazide

Product NDC
71335-1713
11-digit product format
713351713
Labeler code
71335
Product ID
71335-1713_c545f051-9fce-4a1f-b98b-6ef78b63a7ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203561
Marketing category
ANDA
Marketing start
2019-01-14
Substance
HYDROCHLOROTHIAZIDE
Active strength
12.5 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203561-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A203561-001AB

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
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack2b21f3fc-4164-401a-803e-b982dea97e192026-05-14Warnings, Adverse reactionsExact identifier

Warnings cross-check#

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

warnings

WARNINGS 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. Diabetes and Hypoglycemia: Latent diabetes mellitus may become manifest and diabetic patients given thiazides may require adjustment of their insulin dose. Renal Disease: Cumulative effects of the thiazides may develop in patients with impaired renal function. In such patients, thiazides may precipitate azotemia.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The adverse reactions associated with hydrochlorothiazide have been shown to be dose related. In controlled clinical trials, the adverse events reported with doses of 12.5 mg hydrochlorothiazide once daily were comparable to placebo. The following adverse reactions have been reported for doses of hydrochlorothiazide 25 mg and greater and, within each category, are listed in the 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, paresthesia, 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.

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH
Rxcui199903

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
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55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
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59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
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df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1713-1Hydrochlorothiazide30 in 1 BOTTLECAPSULE30106
71335-1713-2Hydrochlorothiazide10 in 1 BOTTLECAPSULE10106
71335-1713-3Hydrochlorothiazide90 in 1 BOTTLECAPSULE90106
71335-1713-4Hydrochlorothiazide100 in 1 BOTTLECAPSULE100106
71335-1713-5Hydrochlorothiazide60 in 1 BOTTLECAPSULE60106
71335-1713-6Hydrochlorothiazide120 in 1 BOTTLECAPSULE120106
71335-1713-7Hydrochlorothiazide7 in 1 BOTTLECAPSULE7106
71335-1713-8Hydrochlorothiazide15 in 1 BOTTLECAPSULE15106
71335-1713-9Hydrochlorothiazide14 in 1 BOTTLECAPSULE14106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1713HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 9 package rows20241225_2b21f3fc-4164-401a-803e-b982dea97e19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN2b21f3fc-4164-401a-803e-b982dea97e19106
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD2b21f3fc-4164-401a-803e-b982dea97e19106
199903HCTZ 12.5 MG Oral CapsuleSY2b21f3fc-4164-401a-803e-b982dea97e19106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1713-17133517130130 CAPSULE in 1 BOTTLE (71335-1713-1) 30 capsule2021-01-150000-00-00NoNoCurrent
71335-1713-27133517130210 CAPSULE in 1 BOTTLE (71335-1713-2) 10 capsule2021-04-120000-00-00NoNoCurrent
71335-1713-37133517130390 CAPSULE in 1 BOTTLE (71335-1713-3) 90 capsule2020-10-020000-00-00NoNoCurrent
71335-1713-471335171304100 CAPSULE in 1 BOTTLE (71335-1713-4) 100 capsule2021-02-120000-00-00NoNoCurrent
71335-1713-57133517130560 CAPSULE in 1 BOTTLE (71335-1713-5) 60 capsule2024-12-100000-00-00NoNoCurrent
71335-1713-671335171306120 CAPSULE in 1 BOTTLE (71335-1713-6) 120 capsule2021-08-120000-00-00NoNoCurrent
71335-1713-7713351713077 CAPSULE in 1 BOTTLE (71335-1713-7) 7 capsule2021-07-020000-00-00NoNoCurrent
71335-1713-87133517130815 CAPSULE in 1 BOTTLE (71335-1713-8) 15 capsule2024-12-100000-00-00NoNoCurrent
71335-1713-97133517130914 CAPSULE in 1 BOTTLE (71335-1713-9) 14 capsule2021-07-020000-00-00NoNoCurrent