Prednisone

Product NDC
49999-028
Requested package NDC
49999-028-60
11-digit product format
499990028
Labeler code
49999
Product ID
49999-028_0d8b6719-907e-49bb-ac00-c53f0b069377
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie medical DBA Quality Care Products LLC
Application
ANDA040256
Marketing category
ANDA
Marketing start
2010-08-11
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
10 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49999-02849999-028-60DDiscontinued 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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

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
A040256-001PREDNISONEPREDNISONE5MGTABLET / ORALAB2002-07-12
A040256-002PREDNISONEPREDNISONE10MGTABLET / ORALAB2002-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040256-001AB
A040256-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040256-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040256-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040256-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040256-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040256-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040256-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040256-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040256-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040256-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040256-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040256-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040256-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040256-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040256-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040256-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040256-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040256-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040256-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040256-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040256-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040256-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040256-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040256-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040256-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040256-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040256-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040256-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040256-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040256-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040256-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040256-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040256-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040256-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040256-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040256-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040256-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040256-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040256-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040256-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040256-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-028-12EA - Each49999-028f7da1625-eca7-428d-8c29-892b911f381312012-07-24
49999-028-14EA - Each49999-028da427039-19f9-4445-a7af-a8a1f011541712012-07-24
49999-028-15EA - Each49999-028730c0144-c742-4d5a-a404-9130b312977c12012-07-24
49999-028-20EA - Each49999-02895e229d1-80d9-4fad-92de-67fe75f81e2f12012-07-24
49999-028-21EA - Each49999-028628281f1-3517-4e53-a132-81ec32ca715612016-12-07
49999-028-30EA - Each49999-0283a301e47-d74e-451e-b8ae-4c8983558a2c12012-07-24
49999-028-40EA - Each49999-0285639d026-9d89-4597-a51f-1454d0cfe70a12012-07-24
49999-028-48EA - Each49999-028b717c8eb-593b-4c88-a1fb-f59356bab88d12012-07-24
49999-028-60EA - Each49999-028b28de529-3046-49dc-8dda-cb2a587e960712013-02-13
49999-028-65EA - Each49999-0281e5358a9-e7c0-4e1d-988d-470d95a0c2a912017-03-06

DailyMed Socrata Ingredients#

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEBryant Ranch Prepack931171e2-0bdb-451e-b737-72ce3ffbed532026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEBryant Ranch Prepack55aedced-d945-4bd2-9aa8-0f18b89a0e7f2026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEBryant Ranch Prepackdc3bbb97-6588-46f4-b0ad-47596874ad0c2026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEBryant Ranch Prepack290a91e5-22ae-4d62-ab34-39a3117002e22026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEREMEDYREPACK INC.746b0bcd-122e-4ea8-a824-28415073a38e2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEMajor Pharmaceuticals57b98930-92ab-4b77-a033-ae9895ee718a2026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEPar Health USA, LLC10fe5a3b-84dc-4600-87c2-b80c97ce18cf2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutionsb5b088b9-8f90-468f-b7a4-a5274aa0aec92026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutions71295010-5adb-499b-a03a-5c78b5e79b2d2026-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONECardinal Health 107, LLC199ed6a6-d9d9-49de-b383-5933a026591b2026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutionsefe0c82b-9dd9-4729-b06f-06307867aca02026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEAmerican Health Packaginga0e8d1a2-8c82-4dc0-8c2f-9da84382f34e2025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONECardinal Health 107, LLC568b8880-7997-4786-8c57-28816ce526552025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEPreferred Pharmaceuticals, Inc.f89bd1dc-88cd-4aef-a7ae-6310f38a34232025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutions95cf05e5-1446-43f5-8447-c04877a747812024-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutions410988ea-456a-454e-932c-fcbdbef04ba92024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutions44069d49-4cf4-4f1e-9fbd-b496c6ca81a12024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEProficient Rx LP7d52bf53-76e3-4826-a12b-b16a8560bafc2021-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEAphena Pharma Solutions - Tennessee, LLCb902ed21-c776-4046-8fbc-9ce95b16b1392017-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49999-028-604999900286060 TABLET in 1 BOTTLE, PLASTIC (49999-028-60) 60 tablet2010-08-110000-00-00NoNoCurrent