Home NDC 50228-112 Hydrochlorothiazide
Product NDC 50228-112
11-digit product format 502280112
Labeler code 50228
Product ID 50228-112_5c6f4c6a-cc43-4f4d-bc16-688310c98c72
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler ScieGen Pharmaceuticals, Inc.
Application ANDA203018
Marketing category ANDA
Marketing start 2014-02-05
Substance HYDROCHLOROTHIAZIDE
Active strength 50 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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203018-001 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 A203018-002 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Hydrochlorothiazide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCHLOROTHIAZIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197770 Internal RxNorm lookup 310798 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50228-112-10 Hydrochlorothiazide 1000 in 1 BOTTLE TABLET 1000 4 50228-112-30 Hydrochlorothiazide 30 in 1 BOTTLE TABLET 30 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.] 2 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK HYDROCHLOROTHIAZIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROCHLOROTHIAZIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCHLOROTHIAZIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCHLOROTHIAZIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HYDROCHLOROTHIAZIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.] 2 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCHLOROTHIAZIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50228-112 HYDROCHLOROTHIAZIDE TABLET [SCIEGEN PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20200613_02e96a51-1d56-460c-8c20-3d6f37e0ce46.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50228-112-10 50228011210 1000 TABLET in 1 BOTTLE (50228-112-10) 1000 tablet 2014-02-05 0000-00-00 No No Current 50228-112-30 50228011230 30 TABLET in 1 BOTTLE (50228-112-30) 30 tablet 2014-02-05 0000-00-00 No No Current