Home NDC 0378-0083-01 Captopril and Hydrochlorothiazide
Product NDC 0378-0083
Requested package NDC 0378-0083-01
11-digit product format 003780083
Labeler code 0378
Product ID 0378-0083_2a59df64-9cc5-4f53-bb80-4d09ca5416c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name captopril and hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA074896
Marketing category ANDA
Marketing start 1997-12-29
Marketing end 0000-00-00
Substance CAPTOPRIL; HYDROCHLOROTHIAZIDE
Active strength 25 mg/1; mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29
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 5 · 176 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 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074896-001 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL 1997-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074896-002 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 25MG;25MG TABLET / ORAL RS 1997-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074896-003 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;25MG TABLET / ORAL 1997-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074896-004 CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG;15MG TABLET / ORAL RS 1997-12-29 2680178bc6a6…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CAPTOPRIL ACTIVE INGREDIENT 9G64RSX1XD CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.] 6 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.] 6 CAPTOPRIL ACTIVE MOIETY 9G64RSX1XD CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.] 6 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.] 6 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.] 6 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHAMACEUTICALS INC.] 6 CAPTOPRIL ACTIVE INGREDIENT 9G64RSX1XD CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CAPTOPRIL ACTIVE MOIETY 9G64RSX1XD CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1
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 0378-0083-01 00378008301 100 TABLET in 1 BOTTLE, PLASTIC (0378-0083-01) 100 tablet 1997-12-29 0000-00-00 No No Current