Sertraline Hydrochloride

Product NDC
65862-011
11-digit product format
658620011
Labeler code
65862
Product ID
65862-011_50d67885-52a9-49a4-9f2a-f82749747222
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077206
Marketing category
ANDA
Marketing start
2007-02-06
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-011UNFINISHEDActive or certified unfinished drug listing2026-08-07
unfinished packagepackage65862-01165862-011-29UNFINISHEDActive or certified unfinished drug listing2026-08-07
unfinished packagepackage65862-01165862-011-59UNFINISHEDActive or certified unfinished drug listing2026-08-07

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 2 · 63 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 packagepackage65862-011-29a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-011-59a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-011-291d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-011-591d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-011-29390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-011-59390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-011-29e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-011-59e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-011-29bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-011-59bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-011-29f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-011-59f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-011-29f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-011-59f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-011-2968b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-011-5968b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-011-2905c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-011-5905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-011-2948b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-011-5948b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-011-2927f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-011-5927f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-011-298d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-011-598d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-011-29d1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-011-59d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-011-2950b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-011-5950b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-011-59906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-011-29906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-011-596db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-011-296db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-011-598fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-011-298fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-011-594184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-011-294184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-011-594bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-011-294bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-011-59263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-011-29263afe128892…91768de4ddbe…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077206-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06
A077206-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06
A077206-003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077206-001AB
A077206-002AB
A077206-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077206-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077206-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077206-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-068072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077206-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077206-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077206-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077206-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077206-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077206-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077206-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077206-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077206-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077206-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077206-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077206-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077206-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077206-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077206-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077206-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077206-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077206-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077206-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077206-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077206-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077206-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077206-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077206-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077206-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077206-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077206-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077206-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077206-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077206-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077206-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077206-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077206-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077206-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077206-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077206-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077206-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077206-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077206-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077206-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UTI8907Y6XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312938Internal RxNorm lookup
312940Internal RxNorm lookup
312941Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
39a85db1-9e59-4ab0-9e18-36757f019faaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-011-01Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10030
65862-011-05Sertraline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50030
65862-011-30Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3030
65862-011-50Sertraline Hydrochloride50 in 1 BOTTLETABLET, FILM COATED5030
65862-011-51Sertraline Hydrochloride5000 in 1 BOTTLETABLET, FILM COATED500030
65862-011-60Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6030
65862-011-90Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9030
65862-011-99Sertraline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-011-01EA - Each65862-0111e7bb4a8-d241-4036-bfb2-51d59c4c6fd912012-07-24
65862-011-05EA - Each65862-0119449c2ef-0eee-48fd-a99c-1088c72edc7c12012-07-24
65862-011-30EA - Each65862-01198d86e4d-14b7-4d3e-9381-8eea7a08a76212012-07-24
65862-011-90EA - Each65862-011036d62be-4035-466e-9753-6fdf3187579612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SERTRALINE HYDROCHLORIDEACTIVE INGREDIENTUTI8907Y6XSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
SERTRALINEACTIVE MOIETYQUC7NX6WMBSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-011SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]30Current NDC, Legacy NDC, 8 package rows20240210_39a85db1-9e59-4ab0-9e18-36757f019faa.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 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.91e24d17-ff0a-449c-9472-b9df74c984562026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.a2f333af-d37b-4705-ab7a-d363e3186e6e2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.561a8a20-be26-c4f8-e063-6394a90af0722026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.561e7498-a606-366d-e063-6394a90a1c6a2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.575da603-b038-421f-9894-6796d9ac33cc2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy8d444aec-cf33-b769-e053-2995a90a54be2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC518caa95-2cd7-a293-e063-6394a90adbd02026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy7f81de84-0ad7-f050-e053-2a91aa0aa7622026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC5103d12c-9453-a855-e063-6294a90a6f0c2026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions7f62789b-61df-4b7b-9e01-c7a4dfb7e73c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions90524e6e-c34f-43eb-8c30-d99faf7ae08f2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthwind Health Company, LLCab0b0ef7-155b-cec9-e053-2a95a90a9fce2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthwind Health Company, LLCab1bb71f-936d-cb40-e053-2a95a90a08bb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEQPharma Inc664d1744-7b1d-43e2-98ba-1b0e69d758402025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAurobindo Pharma Limitedb497dfeb-a48c-4f2a-b309-b56f3a26a19b2025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepackb400fed8-f425-47ff-ab42-915cb6e7f1522025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.8f5a71b2-2821-46a0-ac65-28d9b2db73ec2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3ca30f3f-545e-46c5-b56a-73ec48e9647f2025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.91b4c802-9c6b-49bb-b5a7-661e1917ef342025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.677c90cd-6527-40cb-a564-571796513fcb2025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077206
application number: ANDA077206

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312940sertraline HCl 25 MG Oral TabletPSN5c6c817e-a555-4f55-837d-94458787fcb6102
312940sertraline 25 MG Oral TabletSCD5c6c817e-a555-4f55-837d-94458787fcb6102
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY5c6c817e-a555-4f55-837d-94458787fcb6102
312938sertraline HCl 100 MG Oral TabletPSN286b429d-62b9-4ca8-a243-de3f619315bf37
312940sertraline HCl 25 MG Oral TabletPSN286b429d-62b9-4ca8-a243-de3f619315bf37
312941sertraline HCl 50 MG Oral TabletPSN286b429d-62b9-4ca8-a243-de3f619315bf37
312938sertraline 100 MG Oral TabletSCD286b429d-62b9-4ca8-a243-de3f619315bf37
312940sertraline 25 MG Oral TabletSCD286b429d-62b9-4ca8-a243-de3f619315bf37
312941sertraline 50 MG Oral TabletSCD286b429d-62b9-4ca8-a243-de3f619315bf37
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY286b429d-62b9-4ca8-a243-de3f619315bf37
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY286b429d-62b9-4ca8-a243-de3f619315bf37
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY286b429d-62b9-4ca8-a243-de3f619315bf37
312940sertraline HCl 25 MG Oral TabletPSN0e5a7b02-3972-47f0-9f49-e958d792beac32
312940sertraline 25 MG Oral TabletSCD0e5a7b02-3972-47f0-9f49-e958d792beac32
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY0e5a7b02-3972-47f0-9f49-e958d792beac32
312938sertraline HCl 100 MG Oral TabletPSN39a85db1-9e59-4ab0-9e18-36757f019faa30
312940sertraline HCl 25 MG Oral TabletPSN39a85db1-9e59-4ab0-9e18-36757f019faa30
312941sertraline HCl 50 MG Oral TabletPSN39a85db1-9e59-4ab0-9e18-36757f019faa30
312938sertraline 100 MG Oral TabletSCD39a85db1-9e59-4ab0-9e18-36757f019faa30
312940sertraline 25 MG Oral TabletSCD39a85db1-9e59-4ab0-9e18-36757f019faa30
312941sertraline 50 MG Oral TabletSCD39a85db1-9e59-4ab0-9e18-36757f019faa30
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY39a85db1-9e59-4ab0-9e18-36757f019faa30
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY39a85db1-9e59-4ab0-9e18-36757f019faa30
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY39a85db1-9e59-4ab0-9e18-36757f019faa30
312940sertraline HCl 25 MG Oral TabletPSN575da603-b038-421f-9894-6796d9ac33cc15
312940sertraline 25 MG Oral TabletSCD575da603-b038-421f-9894-6796d9ac33cc15
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY575da603-b038-421f-9894-6796d9ac33cc15
312940sertraline HCl 25 MG Oral TabletPSNb559c20d-70be-41e7-acfb-262ffc3ea8789
312940sertraline 25 MG Oral TabletSCDb559c20d-70be-41e7-acfb-262ffc3ea8789
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYb559c20d-70be-41e7-acfb-262ffc3ea8789
312940sertraline HCl 25 MG Oral TabletPSN6dd71a5b-1923-54fb-e053-2991aa0a619e5
312940sertraline 25 MG Oral TabletSCD6dd71a5b-1923-54fb-e053-2991aa0a619e5
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY6dd71a5b-1923-54fb-e053-2991aa0a619e5
312938sertraline HCl 100 MG Oral TabletPSN06c47a1b-e41a-457d-8a4f-863cece11d1c4
312940sertraline HCl 25 MG Oral TabletPSN06c47a1b-e41a-457d-8a4f-863cece11d1c4
312941sertraline HCl 50 MG Oral TabletPSN06c47a1b-e41a-457d-8a4f-863cece11d1c4
312938sertraline 100 MG Oral TabletSCD06c47a1b-e41a-457d-8a4f-863cece11d1c4
312940sertraline 25 MG Oral TabletSCD06c47a1b-e41a-457d-8a4f-863cece11d1c4
312941sertraline 50 MG Oral TabletSCD06c47a1b-e41a-457d-8a4f-863cece11d1c4
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY06c47a1b-e41a-457d-8a4f-863cece11d1c4
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY06c47a1b-e41a-457d-8a4f-863cece11d1c4
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY06c47a1b-e41a-457d-8a4f-863cece11d1c4
312940sertraline HCl 25 MG Oral TabletPSNb6f306d9-009e-438e-9672-d9f359e4d0da3
312940sertraline 25 MG Oral TabletSCDb6f306d9-009e-438e-9672-d9f359e4d0da3
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYb6f306d9-009e-438e-9672-d9f359e4d0da3
312938sertraline HCl 100 MG Oral TabletPSNe25a13c3-a173-4cc3-99d3-0be43abbc4982
312940sertraline HCl 25 MG Oral TabletPSNe25a13c3-a173-4cc3-99d3-0be43abbc4982
312940sertraline HCl 25 MG Oral TabletPSNbc1abb84-4160-1aee-e053-2995a90af27c2
312940sertraline HCl 25 MG Oral TabletPSNba201164-f6f7-4779-87a3-62780f3321132
312941sertraline HCl 50 MG Oral TabletPSNe25a13c3-a173-4cc3-99d3-0be43abbc4982
312938sertraline 100 MG Oral TabletSCDe25a13c3-a173-4cc3-99d3-0be43abbc4982
312940sertraline 25 MG Oral TabletSCDba201164-f6f7-4779-87a3-62780f3321132
312940sertraline 25 MG Oral TabletSCDbc1abb84-4160-1aee-e053-2995a90af27c2
312940sertraline 25 MG Oral TabletSCDe25a13c3-a173-4cc3-99d3-0be43abbc4982
312941sertraline 50 MG Oral TabletSCDe25a13c3-a173-4cc3-99d3-0be43abbc4982
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYe25a13c3-a173-4cc3-99d3-0be43abbc4982
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYbc1abb84-4160-1aee-e053-2995a90af27c2
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYe25a13c3-a173-4cc3-99d3-0be43abbc4982
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYba201164-f6f7-4779-87a3-62780f3321132
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYe25a13c3-a173-4cc3-99d3-0be43abbc4982
312940sertraline HCl 25 MG Oral TabletPSN8f5a71b2-2821-46a0-ac65-28d9b2db73ec1
312940sertraline 25 MG Oral TabletSCD8f5a71b2-2821-46a0-ac65-28d9b2db73ec1
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY8f5a71b2-2821-46a0-ac65-28d9b2db73ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-011-0165862001101100 TABLET, FILM COATED in 1 BOTTLE (65862-011-01) 2007-02-060000-00-00NoNoCurrent
65862-011-0565862001105500 TABLET, FILM COATED in 1 BOTTLE (65862-011-05) 2007-02-060000-00-00NoNoCurrent
65862-011-296586200112920000 TABLET, FILM COATED in 1 BAG (65862-011-29)06-FEB-07Current
65862-011-306586200113030 TABLET, FILM COATED in 1 BOTTLE (65862-011-30) 2007-02-060000-00-00NoNoCurrent
65862-011-506586200115050 TABLET, FILM COATED in 1 BOTTLE (65862-011-50) 2007-02-060000-00-00NoNoCurrent
65862-011-51658620011515000 TABLET, FILM COATED in 1 BOTTLE (65862-011-51) 2007-02-060000-00-00NoNoCurrent
65862-011-59658620011595000 TABLET, FILM COATED in 1 BAG (65862-011-59)06-FEB-07Current
65862-011-606586200116060 TABLET, FILM COATED in 1 BOTTLE (65862-011-60) 2007-02-060000-00-00NoNoCurrent
65862-011-906586200119090 TABLET, FILM COATED in 1 BOTTLE (65862-011-90) 2007-02-060000-00-00NoNoCurrent
65862-011-99658620011991000 TABLET, FILM COATED in 1 BOTTLE (65862-011-99) 2007-02-060000-00-00NoNoCurrent