FDA.reportPublic FDA data

PredniSONE

Product NDC
51655-701
11-digit product format
516550701
Labeler code
51655
Product ID
51655-701_4950ead0-97a4-b291-e063-6294a90a6026
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA087342
Marketing category
ANDA
Marketing start
2021-04-19
Substance
PREDNISONE
Active strength
20 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.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087342-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087342-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087342-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087342-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087342-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087342-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087342-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087342-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087342-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087342-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087342-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087342-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087342-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087342-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087342-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087342-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087342-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087342-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A087342-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087342-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087342-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087342-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A087342-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087342-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087342-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087342-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087342-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087342-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087342-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087342-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087342-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087342-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087342-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087342-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087342-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087342-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087342-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
PredniSONE
Listing expiration
2027-12-31

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
ca39fdfb-d110-6535-e053-2995a90a550aAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
51655-701-182023-03-27PredniSONE Tablets, USP
51655-701-202023-03-27PredniSONE Tablets, USP
51655-701-532023-03-27PredniSONE Tablets, USP
51655-701-182023-01-30PredniSONE Tablets, USP
51655-701-202023-01-30PredniSONE Tablets, USP
51655-701-532023-01-30PredniSONE Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-701-18PredniSONE18 in 1 BOTTLE, PLASTICTABLET184
51655-701-20PredniSONE20 in 1 BOTTLE, PLASTICTABLET204
51655-701-53PredniSONE10 in 1 BOTTLE, PLASTICTABLET104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-701PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 3 package rows20241228_ca39fdfb-d110-6535-e053-2995a90a550a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PredniSONEPREDNISONENorthwind Health Company, LLCca39fdfb-d110-6535-e053-2995a90a550a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087342
application number: ANDA087342
ndc (product): 51655-701

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNca39fdfb-d110-6535-e053-2995a90a550a4
312615prednisone 20 MG Oral TabletSCDca39fdfb-d110-6535-e053-2995a90a550a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-701-185165507011818 TABLET in 1 BOTTLE, PLASTIC (51655-701-18) 18 tablet2021-06-100000-00-00NoNoCurrent
51655-701-205165507012020 TABLET in 1 BOTTLE, PLASTIC (51655-701-20) 20 tablet2021-06-100000-00-00NoNoCurrent
51655-701-535165507015310 TABLET in 1 BOTTLE, PLASTIC (51655-701-53) 10 tablet2021-04-190000-00-00NoNoCurrent