Prednisone

Product NDC
68788-9309
11-digit product format
687889309
Labeler code
68788
Product ID
68788-9309_efc2782b-d55c-41b4-8529-22e0b0a62952
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA040362
Marketing category
ANDA
Marketing start
2015-03-26
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9309DDiscontinued by firm2026-08-03
excluded packagepackage68788-930968788-9309-1DDiscontinued by firm2026-08-03
excluded packagepackage68788-930968788-9309-2DDiscontinued by firm2026-08-03
excluded packagepackage68788-930968788-9309-3DDiscontinued by firm2026-08-03
excluded packagepackage68788-930968788-9309-4DDiscontinued by firm2026-08-03
excluded packagepackage68788-930968788-9309-5DDiscontinued by firm2026-08-03
excluded packagepackage68788-930968788-9309-6DDiscontinued by firm2026-08-03
excluded packagepackage68788-930968788-9309-7DDiscontinued by firm2026-08-03
excluded packagepackage68788-930968788-9309-8DDiscontinued by firm2026-08-03
excluded packagepackage68788-930968788-9309-9DDiscontinued by firm2026-08-03

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 · 120 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 packagepackage68788-9309-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9309-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9309-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9309-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9309-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9309-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9309-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9309-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9309-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9309-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9309-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9309-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9309-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9309-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9309-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9309-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9309-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9309-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9309-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9309-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9309-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9309-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9309-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9309-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9309-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9309-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9309-52ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9309-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9309-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9309-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9309-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9309-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9309-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9309-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9309-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9309-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9309-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9309-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9309-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9309-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9309-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9309-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9309-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9309-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9309-5cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9309-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9309-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9309-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9309-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9309-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9309-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9309-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9309-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9309-5cdf11ea48f46…ba0047e9e063…

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040362-001PREDNISONEPREDNISONE10MGTABLET / ORALAB2001-08-29
A040362-002PREDNISONEPREDNISONE5MGTABLET / ORALAB2001-08-29
A040362-003PREDNISONEPREDNISONE20MGTABLET / ORALAB2005-06-29
A040362-004PREDNISONEPREDNISONE2.5MGTABLET / ORALAB2023-04-17
A040362-005PREDNISONEPREDNISONE50MGTABLET / ORALAB2023-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A040362-001AB
A040362-002AB
A040362-003AB
A040362-004AB
A040362-005AB

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 · 167 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-175bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 167 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040362-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040362-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-005AB15bbf6a4d5a75…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PrednisoneACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
PrednisoneACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JPREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Starch, PotatoINACTIVE INGREDIENT8I089SAH3TPREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEA-S Medication Solutions74102cc5-7a1a-4a0f-a07f-a4b0f86bcabf2025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEA-S Medication Solutionsdc94273f-af06-4bd5-9ce3-ce0a0f36587b2025-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAdvanced Rx of Tennessee, LLCaf863b9e-964b-3b1e-e053-2995a90ab93a2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAdvanced Rx Pharmacy of Tennessee, LLCb3dbf833-b929-8c85-e053-2995a90a58962024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAdvanced Rx Pharmacy of Tennessee, LLCe1e7d14b-80b2-f57e-e053-2995a90af1122024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAdvanced Rx Pharmacy of Tennessee, LLCb3dbff9f-610f-7782-e053-2a95a90a71c12024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.62fdf3c2-cfa9-d573-e053-2a91aa0a833b2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.62ec965c-e682-9920-e053-2a91aa0adcdb2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.62ff1da3-79aa-676a-e053-2991aa0a4a9f2024-07-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEA-S Medication Solutions751b7f62-f92b-4b7c-a588-2c882d5d1ce32024-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEA-S Medication Solutionscb1b0dc0-6916-4e6f-9775-26ea0f593f832024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.63106192-35d5-6989-e053-2991aa0aa7142024-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEA-S Medication Solutions5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d22024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.63102d75-9b2b-84a9-e053-2a91aa0a317d2024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEProficient Rx LP5961b1d4-6a4c-452f-b3f1-c99f3a9a64452023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAsclemed USA, Inc.dc663fd3-b149-48ae-a3f3-6abaa4808cc62020-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEProficient Rx LPe4555299-af68-416f-8999-9bb703a45e772019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEProficient Rx LP7c650dc8-43f6-4257-81ed-c93b00202d062019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9309-16878893090110 TABLET in 1 BOTTLE (68788-9309-1) 10 tablet2015-03-260000-00-00NoNoCurrent
68788-9309-26878893090220 TABLET in 1 BOTTLE (68788-9309-2) 20 tablet2015-03-260000-00-00NoNoCurrent
68788-9309-36878893090330 TABLET in 1 BOTTLE (68788-9309-3) 30 tablet2015-03-260000-00-00NoNoCurrent
68788-9309-46878893090440 TABLET in 1 BOTTLE (68788-9309-4) 40 tablet2015-03-260000-00-00NoNoCurrent
68788-9309-5687889309059 TABLET in 1 BOTTLE (68788-9309-5) 9 tablet2017-06-220000-00-00NoNoCurrent
68788-9309-66878893090615 TABLET in 1 BOTTLE (68788-9309-6) 15 tablet2015-03-260000-00-00NoNoCurrent
68788-9309-76878893090712 TABLET in 1 BOTTLE (68788-9309-7) 12 tablet2015-03-260000-00-00NoNoCurrent
68788-9309-86878893090821 TABLET in 1 BOTTLE (68788-9309-8) 21 tablet2015-03-260000-00-00NoNoCurrent
68788-9309-96878893090990 TABLET in 1 BOTTLE (68788-9309-9) 90 tablet2015-03-260000-00-00NoNoCurrent