Home NDC 65862-308-49 Fosinopril Sodium and Hydrochlorothiazide
Product NDC 65862-308
Requested package NDC 65862-308-49
11-digit product format 658620308
Labeler code 65862
Product ID 65862-308_34bf0456-37d0-4d7d-a585-1555b7bc9373
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosinopril Sodium and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA079245
Marketing category ANDA
Marketing start 2009-07-09
Substance FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Active strength 10; 12.5 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 2026-12-31
Current FDA listing Yes 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 · 21 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 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
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 A079245-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 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 A079245-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079245-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079245-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079245-001 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 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079245-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079245-001 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 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079245-001 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 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079245-001 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 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079245-001 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 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079245-001 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 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079245-001 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 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079245-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079245-001 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 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079245-001 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 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079245-001 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 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079245-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079245-001 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 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079245-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079245-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A079245-002 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET / ORAL AB RS 2009-07-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079245-001 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET / ORAL AB 2009-07-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A079245-002 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.
Additional Listing Data#
Finished product Yes
Brand name base Fosinopril Sodium and Hydrochlorothiazide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOSINOPRIL SODIUM 10 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NW2RTH6T2N Internal UNII lookup 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 857166 Internal RxNorm lookup 857174 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 65862-308-01 Fosinopril Sodium and Hydrochlorothiazide 100 in 1 BOTTLE TABLET 100 12 65862-308-30 Fosinopril Sodium and Hydrochlorothiazide 30 in 1 BOTTLE TABLET 30 12 65862-308-99 Fosinopril Sodium and Hydrochlorothiazide 1000 in 1 BOTTLE TABLET 1000 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-308 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED] 12 Current NDC, Legacy NDC, 3 package rows 20240430_35019655-9a30-4305-a262-936ad0e73071.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 Status 65862-308-49 65862030849 4000 TABLET in 1 BAG (65862-308-49) 4000 tablet 09-JUL-09 Current