Amlodipine and Olmesartan Medoxomil

Product NDC
13668-313
11-digit product format
136680313
Labeler code
13668
Product ID
13668-313_dc8d740a-a8a3-1d06-e053-2a95a90aa6c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Olmesartan Medoxomil
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA202933
Marketing category
ANDA
Marketing start
2016-11-25
Marketing end
0000-00-00
Substance
AMLODIPINE; OLMESARTAN MEDOXOMIL
Active strength
5 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13668-313DDiscontinued by firm2026-10-05
excluded packagepackage13668-31313668-313-05DDiscontinued by firm2026-10-05
excluded packagepackage13668-31313668-313-10DDiscontinued by firm2026-10-05
excluded packagepackage13668-31313668-313-30DDiscontinued by firm2026-10-05
excluded packagepackage13668-31313668-313-90DDiscontinued by firm2026-10-05

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 · 60 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 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-313-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-313-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-313-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13668-313-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-313-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-313-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-313-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13668-313-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-313-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-313-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-313-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13668-313-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-313-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-313-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-313-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13668-313-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-313-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-313-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-313-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13668-313-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-313-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-313-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-313-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13668-313-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-313-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-313-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-313-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13668-313-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13668-313-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13668-313-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13668-313-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13668-313-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13668-313-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13668-313-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13668-313-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13668-313-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13668-313-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13668-313-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13668-313-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13668-313-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13668-313-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13668-313-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13668-313-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13668-313-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13668-313-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13668-313-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13668-313-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13668-313-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202933-001AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2016-11-25
A202933-002AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2016-11-25
A202933-003AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2016-11-25
A202933-004AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2016-11-25

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202933-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2016-11-2584e616aacf4f…
2026-09-14 22:38:342026-08A202933-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2016-11-2584e616aacf4f…
2026-09-14 22:38:342026-08A202933-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2016-11-2584e616aacf4f…
2026-09-14 22:38:342026-08A202933-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2016-11-2584e616aacf4f…
2026-08-18 06:07:402026-07A202933-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2016-11-25caaa826d4ba7…
2026-08-18 06:07:402026-07A202933-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2016-11-25caaa826d4ba7…
2026-08-18 06:07:402026-07A202933-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2016-11-25caaa826d4ba7…
2026-08-18 06:07:402026-07A202933-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2016-11-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202933-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2016-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202933-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2016-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202933-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2016-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202933-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2016-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202933-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2016-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202933-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2016-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202933-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2016-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202933-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2016-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202933-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2016-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202933-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2016-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202933-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2016-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202933-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2016-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202933-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2016-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202933-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2016-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202933-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2016-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202933-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2016-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202933-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2016-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202933-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2016-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202933-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2016-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202933-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2016-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202933-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2016-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202933-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2016-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202933-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2016-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202933-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2016-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202933-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2016-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202933-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2016-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202933-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2016-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202933-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2016-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202933-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2016-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202933-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2016-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202933-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2016-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202933-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2016-11-255bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202933-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202933-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202933-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202933-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202933-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202933-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202933-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202933-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202933-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202933-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202933-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202933-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202933-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202933-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202933-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202933-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202933-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202933-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202933-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202933-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202933-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202933-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202933-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202933-004AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202933-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202933-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202933-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202933-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202933-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A202933-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A202933-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A202933-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202933-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A202933-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A202933-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A202933-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202933-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A202933-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A202933-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A202933-004AB1c0c555d07b60…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-313-30EA - Each13668-313066923e1-5ae2-40e3-ac4c-7ba58745fb8e12017-04-05
13668-313-90EA - Each13668-313bd2a4a94-6ec7-4591-8c1b-5f72a7af657e12017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-313-0513668031305500 TABLET in 1 BOTTLE (13668-313-05) 500 tablet2016-11-250000-00-00NoNoCurrent
13668-313-10136680313101000 TABLET in 1 BOTTLE (13668-313-10) 1000 tablet2016-11-250000-00-00NoNoCurrent
13668-313-301366803133030 TABLET in 1 BOTTLE (13668-313-30) 30 tablet2016-11-250000-00-00NoNoCurrent
13668-313-7413668031374100 TABLET in 1 BOTTLE (13668-313-74) 100 tablet2016-11-250000-00-00NoNoCurrent
13668-313-901366803139090 TABLET in 1 BOTTLE (13668-313-90) 90 tablet2016-11-250000-00-00NoNoCurrent