Home NDC 68462-554-10 Fosinopril Sodium and Hydrochlorothiazide
Product NDC 68462-554
Requested package NDC 68462-554-10
11-digit product format 684620554
Labeler code 68462
Product ID 68462-554_794e6638-9b32-49d3-988b-3c0f681bac12
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosinopril Sodium and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA090228
Marketing category ANDA
Marketing start 2009-07-09
Marketing end 0000-00-00
Substance FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Active strength 10 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 43 .
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 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09
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 · 86 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 2026-09-14 22:38:34 2026-08 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090228-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090228-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB 2009-07-09 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FOSINOPRIL SODIUM ACTIVE INGREDIENT NW2RTH6T2N FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 FOSINOPRILAT ACTIVE MOIETY S312EY6ZT8 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 SODIUM STEARATE INACTIVE INGREDIENT QU7E2XA9TG FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 3 FOSINOPRIL SODIUM ACTIVE INGREDIENT NW2RTH6T2N FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 FOSINOPRILAT ACTIVE MOIETY S312EY6ZT8 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM STEARATE INACTIVE INGREDIENT QU7E2XA9TG FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U FOSINOPRIL SODIUM 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68462-554-10 68462055410 1000 TABLET in 1 BOTTLE (68462-554-10) 1000 tablet 2009-07-09 0000-00-00 No No Current