prednisone

Product NDC
71335-2149
11-digit product format
713352149
Labeler code
71335
Product ID
71335-2149_e6067ba3-2ab5-4c57-9fb3-1b2225069edc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208412
Marketing category
ANDA
Marketing start
2021-09-01
Substance
PREDNISONE
Active strength
20 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 42.

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
A208412-001PREDNISONEPREDNISONE10MGTABLET / ORALAB2021-02-11
A208412-002PREDNISONEPREDNISONE20MGTABLET / ORALAB2021-02-11
A208412-003PREDNISONEPREDNISONE50MGTABLET / ORALAB2022-01-11
A208412-004PREDNISONEPREDNISONE2.5MGTABLET / ORALAB2020-11-20
A208412-005PREDNISONEPREDNISONE5MGTABLET / ORALAB2020-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208412-001AB
A208412-002AB
A208412-003AB
A208412-004AB
A208412-005AB

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 4 · 131 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-202680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 131 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208412-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208412-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208412-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-005AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE20 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
312615Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9a2d3bee-610b-44dc-8266-869aaf08f0d1Available 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
71335-2149-0prednisone100 in 1 BOTTLETABLET100107
71335-2149-1prednisone6 in 1 BOTTLETABLET6107
71335-2149-2prednisone14 in 1 BOTTLETABLET14107
71335-2149-3prednisone5 in 1 BOTTLETABLET5107
71335-2149-4prednisone10 in 1 BOTTLETABLET10107
71335-2149-5prednisone8 in 1 BOTTLETABLET8107
71335-2149-6prednisone7 in 1 BOTTLETABLET7107
71335-2149-7prednisone24 in 1 BOTTLETABLET24107
71335-2149-8prednisone90 in 1 BOTTLETABLET90107
71335-2149-9prednisone12 in 1 BOTTLETABLET12107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2149PREDNISONE TABLET [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 10 package rows20250330_9a2d3bee-610b-44dc-8266-869aaf08f0d1.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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
prednisonePREDNISONEREMEDYREPACK INC.af5d0f73-2aef-4db1-ae25-6d465c9f0ca12026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.5218e88b-468b-4d60-ab7e-78cca632b23a2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
PrednisonePREDNISONECardinal Health 107, LLCcdc2b903-5d86-45c1-b97c-2da48445dbdd2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONESt. Mary's Medical Park Pharmacye4437eec-eadf-7c8b-e053-2a95a90af8462026-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONECoupler LLC53864d75-06ca-5c2a-e063-6394a90ad9662026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEBryant Ranch Prepackecc48869-3812-4440-a398-749b280620592026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEAmerican Health Packagingfdcd49a6-6cb1-49f8-9f4c-feb475c129b32026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONECardinal Health 107, LLC1d797f3e-a46c-42bc-91bb-c570ae8ca8c22026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.ea4070e1-080d-4feb-9561-3910c6b712dd2026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.b3b70d6f-dc44-4a54-b39b-2762f37d55752026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEQPharma Inc11870c93-fe64-e6c9-e063-6394a90a53342026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEQPharma Incf795ea1d-f41a-6100-e053-6394a90a63a42026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
PrednisonePREDNISONEDirect_Rxf6051257-2144-4487-e053-2995a90a973b2026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEBryant Ranch Prepackfbfd4e2b-3c8f-43c8-bcbe-da1ac4be75c52026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEProficient Rx LP4b37ada5-1f22-46d5-a794-fd1477c0eb9b2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONESportpharm LLC5dde7256-d3b8-400d-a0eb-c60078bfc5d92026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.e9a74862-6a3b-4247-837a-389761b5c3522026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.b540f4af-8f07-4c56-b151-d759440c514a2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEBryant Ranch Prepack70d05ed7-5c4e-4cd1-84cd-0dbe90692c542026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEAsclemed USA, Inc.fdcf3271-fae7-47ef-a370-adbdc0a3cf372026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN9a2d3bee-610b-44dc-8266-869aaf08f0d1107
312615prednisone 20 MG Oral TabletSCD9a2d3bee-610b-44dc-8266-869aaf08f0d1107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2149-071335214900100 TABLET in 1 BOTTLE (71335-2149-0) 100 tablet2024-05-02NoNoCurrent
71335-2149-1713352149016 TABLET in 1 BOTTLE (71335-2149-1) 6 tablet2022-10-060000-00-00NoNoCurrent
71335-2149-27133521490214 TABLET in 1 BOTTLE (71335-2149-2) 14 tablet2022-08-150000-00-00NoNoCurrent
71335-2149-3713352149035 TABLET in 1 BOTTLE (71335-2149-3) 5 tablet2024-05-290000-00-00NoNoCurrent
71335-2149-47133521490410 TABLET in 1 BOTTLE (71335-2149-4) 10 tablet2022-09-060000-00-00NoNoCurrent
71335-2149-5713352149058 TABLET in 1 BOTTLE (71335-2149-5) 8 tablet2024-05-290000-00-00NoNoCurrent
71335-2149-6713352149067 TABLET in 1 BOTTLE (71335-2149-6) 7 tablet2022-08-080000-00-00NoNoCurrent
71335-2149-77133521490724 TABLET in 1 BOTTLE (71335-2149-7) 24 tablet2024-05-020000-00-00NoNoCurrent
71335-2149-87133521490890 TABLET in 1 BOTTLE (71335-2149-8) 90 tablet2024-05-02NoNoCurrent
71335-2149-97133521490912 TABLET in 1 BOTTLE (71335-2149-9) 12 tablet2024-05-02NoNoCurrent