FDA.reportPublic FDA data

hydrochlorothiazide

Product NDC
71205-161
Requested package NDC
71205-161-60
11-digit product format
712050161
Labeler code
71205
Product ID
71205-161_a58f29eb-fe30-469d-89db-eefea2703224
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090510
Marketing category
ANDA
Marketing start
2010-03-15
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090510-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090510-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090510-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2010-01-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090510-001AB1a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydrochlorothiazideHYDROCHLOROTHIAZIDENorthwind Health Company, LLCe3afa83d-c79c-848a-e053-2a95a90ac9222026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma Inc578f74ea-53d1-4c44-b872-66033292abe02025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packaging13ed002f-c5bb-401c-891a-70b70cbd8fb62025-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEQuality Care Products LLCa2de8e26-ef5a-41c7-888b-990629b111452024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack6a11a458-dc69-40ba-a58a-649733e0e8ab2024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions39d4dbd3-8f24-4898-a240-e94e06fa229a2024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.cb7712f3-9a0b-442d-859d-8be5e6e2529a2024-03-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
hydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP98edae8a-99dc-4f26-a956-3ad58bf38a262022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090510
application number: ANDA090510
ndc (package): 71205-161-60
ndc (product): 71205-161
ndc11 (package): 71205016160

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199903Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98edae8a-99dc-4f26-a956-3ad58bf38a26Available on FDA.report

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
71205-161-07hydrochlorothiazide7 in 1 BOTTLE, PLASTICCAPSULE76
71205-161-30hydrochlorothiazide30 in 1 BOTTLE, PLASTICCAPSULE306
71205-161-60hydrochlorothiazide60 in 1 BOTTLE, PLASTICCAPSULE606
71205-161-90hydrochlorothiazide90 in 1 BOTTLE, PLASTICCAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-161-07EA - Each71205-161d01a73b4-f88d-4e23-9bb9-89fe71b29b1812019-08-06
71205-161-30EA - Each71205-161581ccfb5-4d76-4892-93d5-e78e43c9492b12019-06-19
71205-161-90EA - Each71205-161b5289a13-5af8-41b5-87fe-2b9d0771f6b412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-161HYDROCHLOROTHIAZIDE CAPSULE [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20220702_98edae8a-99dc-4f26-a956-3ad58bf38a26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199903hydroCHLOROthiazide 12.5 MG Oral CapsulePSN98edae8a-99dc-4f26-a956-3ad58bf38a266
199903hydrochlorothiazide 12.5 MG Oral CapsuleSCD98edae8a-99dc-4f26-a956-3ad58bf38a266
199903HCTZ 12.5 MG Oral CapsuleSY98edae8a-99dc-4f26-a956-3ad58bf38a266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-161-607120501616060 CAPSULE in 1 BOTTLE, PLASTIC (71205-161-60) 60 capsule2018-11-010000-00-00NoNoCurrent