FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
16729-183
11-digit product format
167290183
Labeler code
16729
Product ID
16729-183_4e6be915-b8a1-bef8-e063-6394a90a324c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202556
Marketing category
ANDA
Marketing start
2013-04-10
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 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
A202556-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2012-09-24
A202556-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-24
A202556-003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-24

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A202556-001AB
A202556-002AB
A202556-003AB

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
HydrochlorothiazideHYDROCHLOROTHIAZIDEAccord Healthcare Inc.babb1b20-fe82-40ba-8e7a-0c56fe433b4a2026-04-01Warnings, 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. 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.

Additional Listing Data#

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

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
16729-183-01Hydrochlorothiazide100 in 1 BOTTLETABLET1006
16729-183-17Hydrochlorothiazide1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-183-01EA - Each16729-1837159ef0b-f97d-4150-a73a-9fe876bb165c12013-05-02
16729-183-17EA - Each16729-183557ccf5f-9739-46c2-8435-c0093e35f87012013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
HydrochlorothiazideACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-183HYDROCHLOROTHIAZIDE TABLET [ACCORD HEALTHCARE INC.]3Current NDC, Legacy NDC, 2 package rows20200902_babb1b20-fe82-40ba-8e7a-0c56fe433b4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310798hydroCHLOROthiazide 25 MG Oral TabletPSNf22a10a2-8f84-4060-9143-427237c51280102
310798hydrochlorothiazide 25 MG Oral TabletSCDf22a10a2-8f84-4060-9143-427237c51280102
310798HCTZ 25 MG Oral TabletSYf22a10a2-8f84-4060-9143-427237c51280102
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSN98a58b54-bcf2-4726-800a-facf48d9155f26
310798hydroCHLOROthiazide 25 MG Oral TabletPSN98a58b54-bcf2-4726-800a-facf48d9155f26
197770hydroCHLOROthiazide 50 MG Oral TabletPSN98a58b54-bcf2-4726-800a-facf48d9155f26
429503hydrochlorothiazide 12.5 MG Oral TabletSCD98a58b54-bcf2-4726-800a-facf48d9155f26
310798hydrochlorothiazide 25 MG Oral TabletSCD98a58b54-bcf2-4726-800a-facf48d9155f26
197770hydrochlorothiazide 50 MG Oral TabletSCD98a58b54-bcf2-4726-800a-facf48d9155f26
429503HCTZ 12.5 MG Oral TabletSY98a58b54-bcf2-4726-800a-facf48d9155f26
310798HCTZ 25 MG Oral TabletSY98a58b54-bcf2-4726-800a-facf48d9155f26
197770HCTZ 50 MG Oral TabletSY98a58b54-bcf2-4726-800a-facf48d9155f26
310798hydroCHLOROthiazide 25 MG Oral TabletPSNfd9b3e5a-f564-4730-8b9f-2cdc2953cbc99
310798hydrochlorothiazide 25 MG Oral TabletSCDfd9b3e5a-f564-4730-8b9f-2cdc2953cbc99
310798HCTZ 25 MG Oral TabletSYfd9b3e5a-f564-4730-8b9f-2cdc2953cbc99
429503hydroCHLOROthiazide 12.5 MG Oral TabletPSNbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
310798hydroCHLOROthiazide 25 MG Oral TabletPSNbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
197770hydroCHLOROthiazide 50 MG Oral TabletPSNbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
429503hydrochlorothiazide 12.5 MG Oral TabletSCDbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
310798hydrochlorothiazide 25 MG Oral TabletSCDbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
197770hydrochlorothiazide 50 MG Oral TabletSCDbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
429503HCTZ 12.5 MG Oral TabletSYbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
310798HCTZ 25 MG Oral TabletSYbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
197770HCTZ 50 MG Oral TabletSYbabb1b20-fe82-40ba-8e7a-0c56fe433b4a6
310798hydroCHLOROthiazide 25 MG Oral TabletPSN3e35fb03-9173-6731-e054-00144ff8d46c5
310798hydroCHLOROthiazide 25 MG Oral TabletPSN51baa232-1b72-494b-a22d-17478c802f445
310798hydrochlorothiazide 25 MG Oral TabletSCD51baa232-1b72-494b-a22d-17478c802f445
310798hydrochlorothiazide 25 MG Oral TabletSCD3e35fb03-9173-6731-e054-00144ff8d46c5
310798HCTZ 25 MG Oral TabletSY51baa232-1b72-494b-a22d-17478c802f445
310798HCTZ 25 MG Oral TabletSY3e35fb03-9173-6731-e054-00144ff8d46c5
310798hydroCHLOROthiazide 25 MG Oral TabletPSN4eb930ca-8dc3-38ba-e054-00144ff8d46c3
310798hydroCHLOROthiazide 25 MG Oral TabletPSN54224596-325d-473e-adb5-1c86857aba343
310798hydroCHLOROthiazide 25 MG Oral TabletPSN7a40a207-fcaa-4e6f-e053-2a91aa0aa29f3
310798hydrochlorothiazide 25 MG Oral TabletSCD54224596-325d-473e-adb5-1c86857aba343
310798hydrochlorothiazide 25 MG Oral TabletSCD4eb930ca-8dc3-38ba-e054-00144ff8d46c3
310798hydrochlorothiazide 25 MG Oral TabletSCD7a40a207-fcaa-4e6f-e053-2a91aa0aa29f3
310798HCTZ 25 MG Oral TabletSY54224596-325d-473e-adb5-1c86857aba343
310798HCTZ 25 MG Oral TabletSY4eb930ca-8dc3-38ba-e054-00144ff8d46c3
310798HCTZ 25 MG Oral TabletSY7a40a207-fcaa-4e6f-e053-2a91aa0aa29f3
310798hydroCHLOROthiazide 25 MG Oral TabletPSNc2db7e27-952f-c3f6-e053-2995a90af7c12
310798hydroCHLOROthiazide 25 MG Oral TabletPSN5a431eed-b974-701a-e053-2991aa0aa6ee2
310798hydroCHLOROthiazide 25 MG Oral TabletPSNf3191ca2-4dbc-01f5-e053-2a95a90a572c2
310798hydroCHLOROthiazide 25 MG Oral TabletPSN9ba391c5-c3d7-4bbe-bbb7-353a2b5280122
310798hydrochlorothiazide 25 MG Oral TabletSCDf3191ca2-4dbc-01f5-e053-2a95a90a572c2
310798hydrochlorothiazide 25 MG Oral TabletSCDc2db7e27-952f-c3f6-e053-2995a90af7c12
310798hydrochlorothiazide 25 MG Oral TabletSCD5a431eed-b974-701a-e053-2991aa0aa6ee2
310798hydrochlorothiazide 25 MG Oral TabletSCD9ba391c5-c3d7-4bbe-bbb7-353a2b5280122
310798HCTZ 25 MG Oral TabletSYc2db7e27-952f-c3f6-e053-2995a90af7c12
310798HCTZ 25 MG Oral TabletSYf3191ca2-4dbc-01f5-e053-2a95a90a572c2
310798HCTZ 25 MG Oral TabletSY5a431eed-b974-701a-e053-2991aa0aa6ee2
310798HCTZ 25 MG Oral TabletSY9ba391c5-c3d7-4bbe-bbb7-353a2b5280122
310798hydroCHLOROthiazide 25 MG Oral TabletPSN7176c8c1-1f7b-88c1-e053-2a95a90a89f01
310798hydroCHLOROthiazide 25 MG Oral TabletPSNcfd6b536-03cb-4b88-81c7-f49c0c76d5a81
310798hydroCHLOROthiazide 25 MG Oral TabletPSN94c500f3-d7c4-43e6-9a39-f8bb7c60c09d1
310798hydrochlorothiazide 25 MG Oral TabletSCDcfd6b536-03cb-4b88-81c7-f49c0c76d5a81
310798hydrochlorothiazide 25 MG Oral TabletSCD94c500f3-d7c4-43e6-9a39-f8bb7c60c09d1
310798hydrochlorothiazide 25 MG Oral TabletSCD7176c8c1-1f7b-88c1-e053-2a95a90a89f01
310798HCTZ 25 MG Oral TabletSYcfd6b536-03cb-4b88-81c7-f49c0c76d5a81
310798HCTZ 25 MG Oral TabletSY7176c8c1-1f7b-88c1-e053-2a95a90a89f01
310798HCTZ 25 MG Oral TabletSY94c500f3-d7c4-43e6-9a39-f8bb7c60c09d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-183-0116729018301100 TABLET in 1 BOTTLE (16729-183-01) 100 tablet2013-04-190000-00-00NoNoCurrent
16729-183-17167290183171000 TABLET in 1 BOTTLE (16729-183-17) 1000 tablet2013-04-100000-00-00NoNoCurrent