FDA.reportPublic FDA data

Fosinopril Sodium and Hydrochlorothiazide

Product NDC
65862-309
11-digit product format
658620309
Labeler code
65862
Product ID
65862-309_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
20; 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

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-309UNFINISHEDActive or certified unfinished drug listing2026-10-05
unfinished packagepackage65862-30965862-309-26UNFINISHEDActive or certified unfinished drug listing2026-10-05

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-309-26a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-309-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-309-26390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-309-26e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-309-26bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-309-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-309-26f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-309-2668b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-309-2605c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-309-2648b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-309-2627f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-309-268d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-309-26d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-309-2650b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-309-26906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-309-266db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-309-268fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-309-264184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-309-264bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-309-26263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproduct5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage65862-309-265b2001dcd8f5…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEFOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09
A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEFOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A079245-001AB
A079245-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-0984e616aacf4f…
2026-09-14 22:38:342026-08A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-0984e616aacf4f…
2026-08-18 06:07:402026-07A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALABRS2009-07-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079245-001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE10MG;12.5MGTABLET / ORALAB2009-07-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079245-002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE20MG;12.5MGTABLET / ORALAB2009-07-0974a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A079245-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A079245-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A079245-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079245-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079245-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079245-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079245-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079245-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079245-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079245-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079245-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079245-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079245-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079245-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079245-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079245-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079245-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079245-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079245-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079245-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079245-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079245-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079245-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079245-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079245-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079245-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079245-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079245-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079245-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079245-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079245-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A079245-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079245-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079245-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079245-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079245-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079245-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079245-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079245-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079245-002AB174a2ff9319b5…

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
IngredientStrength
FOSINOPRIL SODIUM20 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NW2RTH6T2NInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
857166Internal RxNorm lookup
857174Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
35019655-9a30-4305-a262-936ad0e73071Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
90aa3f6a-97f0-be7e-d25b-b26d56ae287eProduct name320201015
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-309-01Fosinopril Sodium and Hydrochlorothiazide100 in 1 BOTTLETABLET10012
65862-309-30Fosinopril Sodium and Hydrochlorothiazide30 in 1 BOTTLETABLET3012
65862-309-99Fosinopril Sodium and Hydrochlorothiazide1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-309-01EA - Each65862-3099f2c9644-b8df-4895-8d66-760b9d201d8912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSINOPRIL SODIUMACTIVE INGREDIENTNW2RTH6T2NFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
FOSINOPRILATACTIVE MOIETYS312EY6ZT8FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
GLYCERYL DISTEARATEINACTIVE INGREDIENT73071MW2KMFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-309FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [AUROBINDO PHARMA LIMITED]12Current NDC, Legacy NDC, 3 package rows20240430_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fosinopril Sodium and HydrochlorothiazideFOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited35019655-9a30-4305-a262-936ad0e730712024-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079245
application number: ANDA079245
ndc (product): 65862-309

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857166fosinopril sodium 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN35019655-9a30-4305-a262-936ad0e7307112
857174fosinopril sodium 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN35019655-9a30-4305-a262-936ad0e7307112
857166fosinopril sodium 10 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD35019655-9a30-4305-a262-936ad0e7307112
857174fosinopril sodium 20 MG / hydrochlorothiazide 12.5 MG Oral TabletSCD35019655-9a30-4305-a262-936ad0e7307112
857166FNP Sodium 10 MG / HCTZ 12.5 MG Oral TabletSY35019655-9a30-4305-a262-936ad0e7307112
857174FNP Sodium 20 MG / HCTZ 12.5 MG Oral TabletSY35019655-9a30-4305-a262-936ad0e7307112
857166fosinopril sodium 10 MG / HCTZ 12.5 MG Oral TabletSY35019655-9a30-4305-a262-936ad0e7307112
857174fosinopril sodium 20 MG / HCTZ 12.5 MG Oral TabletSY35019655-9a30-4305-a262-936ad0e7307112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-309-0165862030901100 TABLET in 1 BOTTLE (65862-309-01) 100 tablet2009-07-090000-00-00NoNoCurrent
65862-309-26658620309262500 TABLET in 1 BAG (65862-309-26)2500 tablet09-JUL-09Current
65862-309-306586203093030 TABLET in 1 BOTTLE (65862-309-30) 30 tablet2009-07-090000-00-00NoNoCurrent
65862-309-99658620309991000 TABLET in 1 BOTTLE (65862-309-99) 1000 tablet2009-07-090000-00-00NoNoCurrent