PredniSONE Tablets, USP, 5 mg

Product NDC
72789-474
11-digit product format
727890474
Labeler code
72789
Product ID
72789-474_4ddfaff7-3273-e76e-e063-6294a90a01c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA212629
Marketing category
ANDA
Marketing start
2025-05-22
Substance
PREDNISONE
Active strength
5 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212629-001PREDNISONEPREDNISONE5MGTABLET / ORALAB2023-12-05
A212629-002PREDNISONEPREDNISONE10MGTABLET / ORALAB2023-12-05
A212629-003PREDNISONEPREDNISONE20MGTABLET / ORALAB2023-12-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A212629-001AB
A212629-002AB
A212629-003AB

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 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212629-001PREDNISONE5MGTABLET / ORALAB2023-12-0584e616aacf4f…
2026-09-14 22:38:342026-08A212629-002PREDNISONE10MGTABLET / ORALAB2023-12-0584e616aacf4f…
2026-09-14 22:38:342026-08A212629-003PREDNISONE20MGTABLET / ORALAB2023-12-0584e616aacf4f…
2026-08-18 06:07:402026-07A212629-001PREDNISONE5MGTABLET / ORALAB2023-12-05caaa826d4ba7…
2026-08-18 06:07:402026-07A212629-002PREDNISONE10MGTABLET / ORALAB2023-12-05caaa826d4ba7…
2026-08-18 06:07:402026-07A212629-003PREDNISONE20MGTABLET / ORALAB2023-12-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212629-001PREDNISONE5MGTABLET / ORALAB2023-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212629-002PREDNISONE10MGTABLET / ORALAB2023-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212629-003PREDNISONE20MGTABLET / ORALAB2023-12-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212629-001PREDNISONE5MGTABLET / ORALAB2023-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212629-002PREDNISONE10MGTABLET / ORALAB2023-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212629-003PREDNISONE20MGTABLET / ORALAB2023-12-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A212629-001PREDNISONE5MGTABLET / ORALAB2023-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212629-002PREDNISONE10MGTABLET / ORALAB2023-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212629-003PREDNISONE20MGTABLET / ORALAB2023-12-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212629-001PREDNISONE5MGTABLET / ORALAB2023-12-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212629-002PREDNISONE10MGTABLET / ORALAB2023-12-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212629-003PREDNISONE20MGTABLET / ORALAB2023-12-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212629-001PREDNISONE5MGTABLET / ORALAB2023-12-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212629-002PREDNISONE10MGTABLET / ORALAB2023-12-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212629-003PREDNISONE20MGTABLET / ORALAB2023-12-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212629-001PREDNISONE5MGTABLET / ORALAB2023-12-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212629-002PREDNISONE10MGTABLET / ORALAB2023-12-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212629-003PREDNISONE20MGTABLET / ORALAB2023-12-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212629-001PREDNISONE5MGTABLET / ORAL2023-12-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212629-002PREDNISONE10MGTABLET / ORAL2023-12-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212629-003PREDNISONE20MGTABLET / ORAL2023-12-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212629-001PREDNISONE5MGTABLET / ORAL2023-12-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212629-002PREDNISONE10MGTABLET / ORAL2023-12-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212629-003PREDNISONE20MGTABLET / ORAL2023-12-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212629-001PREDNISONE5MGTABLET / ORAL2023-12-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212629-002PREDNISONE10MGTABLET / ORAL2023-12-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212629-003PREDNISONE20MGTABLET / ORAL2023-12-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212629-001PREDNISONE5MGTABLET / ORAL2023-12-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A212629-002PREDNISONE10MGTABLET / ORAL2023-12-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A212629-003PREDNISONE20MGTABLET / ORAL2023-12-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212629-001PREDNISONE5MGTABLET / ORAL2023-12-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212629-002PREDNISONE10MGTABLET / ORAL2023-12-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212629-003PREDNISONE20MGTABLET / ORAL2023-12-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212629-001PREDNISONE5MGTABLET / ORALAB2023-12-05301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212629-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A212629-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A212629-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A212629-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212629-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212629-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212629-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212629-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212629-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212629-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212629-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212629-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212629-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212629-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212629-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212629-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212629-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212629-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212629-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212629-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212629-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212629-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212629-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212629-003AB103ed91905a0d…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212629-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212629-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212629-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212629-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212629-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212629-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212629-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212629-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212629-003AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212629-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212629-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212629-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212629-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A212629-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A212629-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212629-001AB1ea1830bbd6c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
PredniSONE Tablets, USP, 5 mg
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE5 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
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
d6df3295-3118-49af-be05-b1fab0d4adaaAvailable 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
72789-474-01PredniSONE Tablets, USP, 5 mg100 in 1 BOTTLE, PLASTICTABLET1008
72789-474-04PredniSONE Tablets, USP, 5 mg4 in 1 BOTTLE, PLASTICTABLET48
72789-474-21PredniSONE Tablets, USP, 5 mg21 in 1 BOTTLE, PLASTICTABLET218
72789-474-95PredniSONE Tablets, USP, 5 mg1000 in 1 BOTTLE, PLASTICTABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-474-01EA - Each72789-47405788a5a-febb-4e16-b509-1132b0b0f0b012025-05-14
72789-474-04EA - Each72789-4747b0878e5-4522-4ff3-841e-8aa65de9747e12026-01-08
72789-474-21EA - Each72789-4747259863f-7ada-4612-9693-e724b93b127312025-10-14
72789-474-95EA - Each72789-474d5b41f51-f422-4470-973a-8528d86f35ce12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-474PREDNISONE TABLETS, USP, 5 MG (PREDNISONE) TABLET [PD-RX PHARMACEUTICALS, INC.]3Current NDC, 4 package rows20250214_d6df3295-3118-49af-be05-b1fab0d4adaa.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.6b360c1f-c862-47ee-a40e-3903c2d6162f2026-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.15230866-f547-47bf-ac7d-19afd6a41e2e2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 10 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.bb32e309-e3c7-4009-bcd4-d97545b7e9752026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 5 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.251e9fe7-b1f5-4b5b-b5fa-8c8be43e284e2026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.3befbdc5-7d20-41b6-ad80-98e1c6b8caf52026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 5 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.d6df3295-3118-49af-be05-b1fab0d4adaa2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
ndc (product): 72789-474
PredniSONE Tablets, USP, 10 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.14d50f54-410b-45b2-a639-31498ceaf8542026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 20 mgPREDNISONEBryant Ranch Prepack852ea185-1bda-4c89-a192-ee0f93cba4282026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 5 mgPREDNISONEBryant Ranch Prepack475c6480-2a6a-4698-aff3-7affb154f2a72025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 20 mgPREDNISONEBryant Ranch Prepack0e55a02d-2de4-42c4-adc2-49536b8992252025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 10 mgPREDNISONEBryant Ranch Prepack61dab6c2-4019-4d7c-bc8b-3a0a463beefc2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 20 mgPREDNISONEBryant Ranch Prepack53bd04e8-6cbd-45f6-ac59-53fd3005a2212025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 10 mgPREDNISONEBryant Ranch Prepack8520622e-c0e3-4226-be84-e332ab98e6a72025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 5 mgPREDNISONEBryant Ranch Prepack5e5c81bf-7cbb-4f02-b107-16efe3d353ee2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 5 mgPREDNISONEBryant Ranch Prepack83e825cc-fb19-48b9-9f15-6aba6b1cef572025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 10 mgPREDNISONEBryant Ranch Prepack95b7de4c-9c69-45f6-9221-a2c87c441b042025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 5 mgPREDNISONEBryant Ranch Prepack419058f7-7f30-41a1-964b-8eaa69290dea2025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 20 mgPREDNISONEBryant Ranch Prepackb42adc18-21cc-4fe0-bf7d-fb76f4cda2152025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 20 mgPREDNISONEBryant Ranch Prepackbfcc98b8-184e-4db4-8079-de88958c774b2025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629
PredniSONE Tablets, USP, 10 mgPREDNISONEBryant Ranch Prepackaba52f0c-0706-46ac-957d-e53963d354992025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212629
application number: ANDA212629

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSNd6df3295-3118-49af-be05-b1fab0d4adaa8
312617prednisone 5 MG Oral TabletSCDd6df3295-3118-49af-be05-b1fab0d4adaa8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-474-0172789047401100 TABLET in 1 BOTTLE, PLASTIC (72789-474-01) 100 tablet2025-05-22NoNoCurrent
72789-474-04727890474044 TABLET in 1 BOTTLE, PLASTIC (72789-474-04) 4 tablet2025-12-24NoNoCurrent
72789-474-217278904742121 TABLET in 1 BOTTLE, PLASTIC (72789-474-21) 21 tablet2025-09-03NoNoCurrent
72789-474-95727890474951000 TABLET in 1 BOTTLE, PLASTIC (72789-474-95) 1000 tablet2025-05-22NoNoCurrent