Prednisone

Product NDC
51655-410
11-digit product format
516550410
Labeler code
51655
Product ID
51655-410_48ff0341-60c9-05c3-e063-6294a90a031b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA085162
Marketing category
ANDA
Marketing start
2014-04-28
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 21 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-410-49IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-410-20IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-410-49IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-410-20IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-410-49IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-410-20IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-410-49IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-410-20IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-410-49IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-410-20IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-410-49IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-410-20IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51655-410-20EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51655-410-49EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085162-001PREDNISONEPREDNISONE10MGTABLET / ORALABApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A085162-001AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085162-001PREDNISONE10MGTABLET / ORALABApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085162-001PREDNISONE10MGTABLET / ORALABApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085162-001PREDNISONE10MGTABLET / ORALABApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085162-001PREDNISONE10MGTABLET / ORALABApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085162-001PREDNISONE10MGTABLET / ORALABApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085162-001PREDNISONE10MGTABLET / ORALABApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085162-001PREDNISONE10MGTABLET / ORALABApproved before 1982e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A085162-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A085162-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085162-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085162-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085162-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085162-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085162-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085162-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085162-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085162-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085162-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085162-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085162-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085162-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085162-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085162-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085162-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085162-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085162-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085162-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085162-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085162-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A085162-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085162-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085162-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085162-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A085162-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085162-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085162-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085162-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085162-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085162-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085162-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085162-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085162-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A085162-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A085162-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085162-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085162-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085162-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Prednisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VB0R961HZTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198145Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f377d9f-b2f4-4dae-b503-5f963bea281fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-410-20Prednisone20 in 1 BOTTLETABLET206
51655-410-21Prednisone21 in 1 BOTTLE, PLASTICTABLET216
51655-410-27Prednisone12 in 1 BOTTLE, PLASTICTABLET126
51655-410-49Prednisone42 in 1 BOTTLETABLET426
51655-410-52Prednisone30 in 1 BOTTLE, PLASTICTABLET306
51655-410-53Prednisone10 in 1 BOTTLE, PLASTICTABLET106
51655-410-54Prednisone15 in 1 BOTTLE, PLASTICTABLET156

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [NORTHWIND PHARMACEUTICALS]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [NORTHWIND PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-410PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 7 package rows20241220_0f377d9f-b2f4-4dae-b503-5f963bea281f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONERedpharm Drug5407a00b-1bfb-e37d-e063-6294a90a6c412026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085162
application number: ANDA085162
Prednisone D/PPREDNISONE D/PDirect_Rx41ade439-59f2-dfd1-e063-6294a90aca0f2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085162
application number: ANDA085162
PrednisonePREDNISONENorthwind Health Company, LLC0f377d9f-b2f4-4dae-b503-5f963bea281f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085162
application number: ANDA085162
ndc (product): 51655-410
PrednisonePREDNISONEQPharma, Inc.07fb8daa-2ceb-4564-b0d0-6cdf903da0b52025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085162
application number: ANDA085162
PrednisonePREDNISONEAdvanced Rx of Tennessee, LLC309580a7-c3bb-e53b-e063-6394a90a15632025-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085162
application number: ANDA085162
PrednisonePREDNISONEActavis Pharma, Inc.aa0b1582-6ef3-4697-9ea6-5391e6e578532024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085162
application number: ANDA085162
PrednisonePREDNISONEProficient Rx LP94f8ec56-667e-4eda-832d-f2936f12dc362024-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085162
application number: ANDA085162

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN0f377d9f-b2f4-4dae-b503-5f963bea281f6
198145prednisone 10 MG Oral TabletSCD0f377d9f-b2f4-4dae-b503-5f963bea281f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-410-205165504102020 TABLET in 1 BOTTLE (51655-410-20) 20 tablet2014-04-28NoNoCurrent
51655-410-215165504102121 TABLET in 1 BOTTLE, PLASTIC (51655-410-21) 21 tablet2021-06-10NoNoCurrent
51655-410-275165504102712 TABLET in 1 BOTTLE, PLASTIC (51655-410-27) 12 tablet2023-03-03NoNoCurrent
51655-410-495165504104942 TABLET in 1 BOTTLE (51655-410-49) 42 tablet2014-04-28NoNoCurrent
51655-410-525165504105230 TABLET in 1 BOTTLE, PLASTIC (51655-410-52) 30 tablet2020-04-10NoNoCurrent
51655-410-535165504105310 TABLET in 1 BOTTLE, PLASTIC (51655-410-53) 10 tablet2023-03-15NoNoCurrent
51655-410-545165504105415 TABLET in 1 BOTTLE, PLASTIC (51655-410-54) 15 tablet2021-05-12NoNoCurrent