Home NDC 65862-471 Fosinopril Sodium
Product NDC 65862-471
11-digit product format 658620471
Labeler code 65862
Product ID 65862-471_8767ee1b-3d50-4a6f-bb59-6c15ccfde78d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosinopril Sodium
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA091163
Marketing category ANDA
Marketing start 2011-03-30
Substance FOSINOPRIL SODIUM
Active strength 10 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 65862-471 UNFINISHED Active or certified unfinished drug listing 2026-10-30 unfinished package package 65862-471 65862-471-49 UNFINISHED Active or certified unfinished drug listing 2026-10-30
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 · 40 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 65862-471-49 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 65862-471-49 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 65862-471-49 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 65862-471-49 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 65862-471-49 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 65862-471-49 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 65862-471-49 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 65862-471-49 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 65862-471-49 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 65862-471-49 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 65862-471-49 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 65862-471-49 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 65862-471-49 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 65862-471-49 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 65862-471-49 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 65862-471-49 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 65862-471-49 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 65862-471-49 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 65862-471-49 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 65862-471-49 263afe128892…91768de4ddbe…
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 A091163-001 FOSINOPRIL SODIUM FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 A091163-002 FOSINOPRIL SODIUM FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 A091163-003 FOSINOPRIL SODIUM FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30
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 4 · 132 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 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091163-002 FOSINOPRIL SODIUM 20MG TABLET / ORAL AB 2011-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091163-003 FOSINOPRIL SODIUM 40MG TABLET / ORAL AB 2011-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091163-001 FOSINOPRIL SODIUM 10MG TABLET / ORAL AB 2011-03-30 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOSINOPRIL SODIUM 10 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65862-471-30 Fosinopril Sodium 30 in 1 BOTTLE TABLET 30 8 65862-471-90 Fosinopril Sodium 90 in 1 BOTTLE TABLET 90 8 65862-471-99 Fosinopril Sodium 1000 in 1 BOTTLE TABLET 1000 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-471 FOSINOPRIL SODIUM TABLET [AUROBINDO PHARMA LIMITED] 8 Current NDC, Legacy NDC, 3 package rows 20240518_aee04f17-8ee9-42f5-861f-b6ba17220ca4.zip
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 65862-471-30 65862047130 30 TABLET in 1 BOTTLE (65862-471-30) 30 tablet 2011-03-30 0000-00-00 No No Current 65862-471-49 65862047149 4000 TABLET in 1 BAG (65862-471-49) 4000 tablet 30-MAR-11 Current 65862-471-90 65862047190 90 TABLET in 1 BOTTLE (65862-471-90) 90 tablet 2011-03-30 0000-00-00 No No Current 65862-471-99 65862047199 1000 TABLET in 1 BOTTLE (65862-471-99) 1000 tablet 2011-03-30 0000-00-00 No No Current