Home NDC 60760-315 Hydrochlorothiazide
Product NDC 60760-315
11-digit product format 607600315
Labeler code 60760
Product ID 60760-315_5b359bf5-3209-c172-e063-6394a90ae65c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler St. Mary's Medical Park Pharmacy
Application ANDA040907
Marketing category ANDA
Marketing start 2019-05-30
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040907-001 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 A040907-002 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 A040907-003 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 95 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 2026-10-15 13:18:30 2026-09 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A040907-003 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040907-003 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040907-003 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040907-003 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040907-003 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040907-003 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2025-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040907-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2008-08-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040907-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2008-08-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 95 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCHLOROTHIAZIDE 25 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60760-315-30 Hydrochlorothiazide 30 in 1 BOTTLE, PLASTIC TABLET 30 2 60760-315-90 Hydrochlorothiazide 90 in 1 BOTTLE, PLASTIC TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60760-315 HYDROCHLOROTHIAZIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY] 1 Current NDC, Legacy NDC, 2 package rows 20190605_8a1de4e2-3aca-a4d3-e053-2995a90a1a41.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 2 of 2 · 21 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 60760-315-30 60760031530 30 TABLET in 1 BOTTLE, PLASTIC (60760-315-30) 30 tablet 2019-05-30 0000-00-00 No No Current 60760-315-90 60760031590 90 TABLET in 1 BOTTLE, PLASTIC (60760-315-90) 90 tablet 2019-05-30 0000-00-00 No No Current