Prednisone

Product NDC
60687-134
11-digit product format
606870134
Labeler code
60687
Product ID
60687-134_46a0c9d3-8ce8-d59e-e063-6294a90ab258
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040256
Marketing category
ANDA
Marketing start
2015-09-14
Marketing end
2026-09-30
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
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

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198145Internal RxNorm lookup
312615Internal 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
a0e8d1a2-8c82-4dc0-8c2f-9da84382f34eAvailable 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
60687-134-01Prednisone100 in 1 BOX, UNIT-DOSETABLET10010
60687-134-11Prednisone1 in 1 BLISTER PACKTABLET110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-134-01EA - Each60687-134a50a0ab3-1945-4394-8fec-fb2de000cc5b12015-10-02
60687-134-11EA - Each60687-134b76e9b9c-c8af-48f8-86a1-8ee660ec713412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-134PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 2 package rows20240828_a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e.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
ndc (product): 60687-134
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNa0e8d1a2-8c82-4dc0-8c2f-9da84382f34e10
312615predniSONE 20 MG Oral TabletPSNa0e8d1a2-8c82-4dc0-8c2f-9da84382f34e10
312617predniSONE 5 MG Oral TabletPSNa0e8d1a2-8c82-4dc0-8c2f-9da84382f34e10
198145prednisone 10 MG Oral TabletSCDa0e8d1a2-8c82-4dc0-8c2f-9da84382f34e10
312615prednisone 20 MG Oral TabletSCDa0e8d1a2-8c82-4dc0-8c2f-9da84382f34e10
312617prednisone 5 MG Oral TabletSCDa0e8d1a2-8c82-4dc0-8c2f-9da84382f34e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-134-0160687013401100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-134-01) / 1 TABLET in 1 BLISTER PACK (60687-134-11) 100 blister pack2015-09-142026-09-30NoNoCurrent
60687-134-11606870134111 in 1 BLISTER PACKHistorical