Prednisone

Product NDC
63187-037
11-digit product format
631870037
Labeler code
63187
Product ID
63187-037_c1b5fac9-ec3d-491f-8e58-bba1d0f9d861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040256
Marketing category
ANDA
Marketing start
2002-07-12
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

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

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198145Internal RxNorm lookup
312617Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d52bf53-76e3-4826-a12b-b16a8560bafcAvailable 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
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-037-05Prednisone5 in 1 BOTTLE, PLASTICTABLET59
63187-037-08Prednisone8 in 1 BOTTLE, PLASTICTABLET89
63187-037-09Prednisone9 in 1 BOTTLE, PLASTICTABLET99
63187-037-10Prednisone10 in 1 BOTTLE, PLASTICTABLET109
63187-037-20Prednisone20 in 1 BOTTLE, PLASTICTABLET209
63187-037-21Prednisone21 in 1 BOTTLE, PLASTICTABLET219
63187-037-30Prednisone30 in 1 BOTTLE, PLASTICTABLET309
63187-037-40Prednisone40 in 1 BOTTLE, PLASTICTABLET409
63187-037-42Prednisone42 in 1 BOTTLE, PLASTICTABLET429

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-037-20EA - Each63187-037ee379532-13a2-4d7d-96bf-a228afdb9f4b12016-06-14
63187-037-21EA - Each63187-037f5dd3703-12cf-4db1-a620-9d4b3f7403dd12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [PROFICIENT RX LP]4
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [PROFICIENT RX LP]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [PROFICIENT RX LP]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [PROFICIENT RX LP]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [PROFICIENT RX LP]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [PROFICIENT RX LP]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [PROFICIENT RX LP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-037PREDNISONE TABLET [PROFICIENT RX LP]9Current NDC, Legacy NDC, 9 package rows20210508_7d52bf53-76e3-4826-a12b-b16a8560bafc.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 · 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
ndc (product): 63187-037
PrednisonePREDNISONEAphena Pharma Solutions - Tennessee, LLCb902ed21-c776-4046-8fbc-9ce95b16b1392017-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN7d52bf53-76e3-4826-a12b-b16a8560bafc9
312617predniSONE 5 MG Oral TabletPSN7d52bf53-76e3-4826-a12b-b16a8560bafc9
198145prednisone 10 MG Oral TabletSCD7d52bf53-76e3-4826-a12b-b16a8560bafc9
312617prednisone 5 MG Oral TabletSCD7d52bf53-76e3-4826-a12b-b16a8560bafc9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-037-05631870037055 TABLET in 1 BOTTLE, PLASTIC (63187-037-05) 5 tablet2014-08-010000-00-00NoNoCurrent
63187-037-08631870037088 TABLET in 1 BOTTLE, PLASTIC (63187-037-08) 8 tablet2014-08-010000-00-00NoNoCurrent
63187-037-09631870037099 TABLET in 1 BOTTLE, PLASTIC (63187-037-09) 9 tablet2014-08-010000-00-00NoNoCurrent
63187-037-106318700371010 TABLET in 1 BOTTLE, PLASTIC (63187-037-10) 10 tablet2014-08-010000-00-00NoNoCurrent
63187-037-206318700372020 TABLET in 1 BOTTLE, PLASTIC (63187-037-20) 20 tablet2014-08-010000-00-00NoNoCurrent
63187-037-216318700372121 TABLET in 1 BOTTLE, PLASTIC (63187-037-21) 21 tablet2014-08-010000-00-00NoNoCurrent
63187-037-306318700373030 TABLET in 1 BOTTLE, PLASTIC (63187-037-30) 30 tablet2014-08-010000-00-00NoNoCurrent
63187-037-406318700374040 TABLET in 1 BOTTLE, PLASTIC (63187-037-40) 40 tablet2014-08-010000-00-00NoNoCurrent
63187-037-426318700374242 TABLET in 1 BOTTLE, PLASTIC (63187-037-42) 42 tablet2014-08-010000-00-00NoNoCurrent