PredniSONE Tablets, USP, 5 mg

Product NDC
72789-474
Requested package NDC
72789-474-95
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 1.

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 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212629-001PREDNISONE5MGTABLET / 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212629-002PREDNISONE10MGTABLET / ORALAB2023-12-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212629-003PREDNISONE20MGTABLET / ORALAB2023-12-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212629-001PREDNISONE5MGTABLET / ORALAB2023-12-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212629-002PREDNISONE10MGTABLET / ORALAB2023-12-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212629-003PREDNISONE20MGTABLET / ORALAB2023-12-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212629-001PREDNISONE5MGTABLET / ORALAB2023-12-058072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2023-12-20 04:57 UTC2023-12A212629-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A212629-003AB1ea1830bbd6c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212629-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212629-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212629-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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.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, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.6b360c1f-c862-47ee-a40e-3903c2d6162f2026-04-06Warnings, 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 (package): 72789-474-95
ndc (product): 72789-474
ndc11 (package): 72789047495
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

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

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
72789-474-95727890474951000 TABLET in 1 BOTTLE, PLASTIC (72789-474-95) 1000 tablet2025-05-22NoNoCurrent