PREDNISONE

Product NDC
61919-326
Requested package NDC
61919-326-30
11-digit product format
619190326
Labeler code
61919
Product ID
61919-326_f2127f51-a0aa-9fe2-e053-2a95a90a8cd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA080356
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-32661919-326-30IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080356-001PREDNISONEPREDNISONE5MGTABLET / ORALABApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A080356-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080356-001PREDNISONE5MGTABLET / ORALABApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080356-001PREDNISONE5MGTABLET / ORALABApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080356-001PREDNISONE5MGTABLET / ORALABApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080356-001PREDNISONE5MGTABLET / ORALABApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080356-001PREDNISONE5MGTABLET / ORALABApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080356-001PREDNISONE5MGTABLET / ORALABApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080356-001PREDNISONE5MGTABLET / ORALABApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A080356-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080356-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080356-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080356-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080356-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080356-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080356-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080356-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080356-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080356-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080356-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080356-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080356-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080356-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080356-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080356-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080356-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080356-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080356-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080356-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080356-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A080356-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080356-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080356-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080356-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A080356-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A080356-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080356-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080356-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080356-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080356-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080356-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080356-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080356-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A080356-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A080356-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080356-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080356-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080356-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080356-001AB1cb3db0bc1861…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-326-05PREDNISONE5 in 1 BLISTER PACKTABLET59
61919-326-21PREDNISONE21 in 1 BOTTLETABLET219
61919-326-30PREDNISONE30 in 1 BOTTLETABLET309
61919-326-10PREDNISONE10 in 1 BOTTLETABLET101
61919-326-15PREDNISONE15 in 1 BOTTLETABLET151
61919-326-20PREDNISONE20 in 1 BOTTLETABLET201
61919-326-23PREDNISONE23 in 1 BOTTLETABLET231

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-326-05EA - Each61919-326031d9661-d04f-46cd-acd9-81fd6a87899f12022-10-06
61919-326-10EA - Each61919-326f95f94c9-8c97-4463-827a-ce53a24e681512019-09-05
61919-326-15EA - Each61919-326b685e592-3c41-4440-8b6b-a8b05b2c198212019-10-07
61919-326-20EA - Each61919-32670fc73c6-3019-40c5-b63d-566d6492dbdd12019-10-07
61919-326-21EA - Each61919-3263c0cd173-8bc9-49b6-9226-269d1ac126d612014-07-02
61919-326-23EA - Each61919-326c1446ea1-e74c-4df2-b1d3-7f55b755553112019-09-05
61919-326-30EA - Each61919-32626150596-03eb-4c76-a82f-2d6d8cda67b012022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [DIRECT RX]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [DIRECT RX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREDNISONE TABLET [DIRECT RX]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PREDNISONE TABLET [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [DIRECT RX]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREDNISONE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-326PREDNISONE TABLET [DIRECT_RX]9Legacy NDC, 3 package rows20230420_d9b1652b-820a-4971-ab71-58bd55908b4d.zip
61919-326PREDNISONE TABLET [DIECT_RX]1Legacy NDC, 1 package rows20190808_8f8cc292-4417-0a3b-e053-2a95a90ace3a.zip
61919-326PREDNISONE TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190724_8e6dceeb-132f-f12d-e053-2995a90a2241.zip
61919-326PREDNISONE TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190906_91ce3df8-9d2b-5479-e053-2a95a90aab84.zip
61919-326PREDNISONE TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190917_92ad0264-035e-b12a-e053-2a95a90a684e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEREMEDYREPACK INC.4bd86b2f-75cb-4711-85e2-b81ed947cb132026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080356
application number: ANDA080356
PrednisonePREDNISONEQPharma, Inc.f4d5974a-444f-4ef0-84a9-803150ccdeac2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080356
application number: ANDA080356
PrednisonePREDNISONEActavis Pharma, Inc.aa0b1582-6ef3-4697-9ea6-5391e6e578532024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080356
application number: ANDA080356
PrednisonePREDNISONEPharmPak, Inc.03aaf69f-d9c7-433c-baea-9c6eca0fe1e52022-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080356
application number: ANDA080356
PrednisonePREDNISONEProficient Rx LPa1bff575-cd79-4596-99f1-30a5fe8a8b4c2022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080356
application number: ANDA080356

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNd9b1652b-820a-4971-ab71-58bd55908b4d9
312615prednisone 20 MG Oral TabletSCDd9b1652b-820a-4971-ab71-58bd55908b4d9
312615predniSONE 20 MG Oral TabletPSN8e6dceeb-132f-f12d-e053-2995a90a22411
312615predniSONE 20 MG Oral TabletPSN8f8cc292-4417-0a3b-e053-2a95a90ace3a1
312615predniSONE 20 MG Oral TabletPSN91ce3df8-9d2b-5479-e053-2a95a90aab841
312615predniSONE 20 MG Oral TabletPSN92ad0264-035e-b12a-e053-2a95a90a684e1
312615prednisone 20 MG Oral TabletSCD8e6dceeb-132f-f12d-e053-2995a90a22411
312615prednisone 20 MG Oral TabletSCD8f8cc292-4417-0a3b-e053-2a95a90ace3a1
312615prednisone 20 MG Oral TabletSCD91ce3df8-9d2b-5479-e053-2a95a90aab841
312615prednisone 20 MG Oral TabletSCD92ad0264-035e-b12a-e053-2a95a90a684e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-326-306191903263030 TABLET in 1 BOTTLE (61919-326-30) 30 tablet2022-09-190000-00-00NoNoCurrent