prednisone

Product NDC
50090-5816
11-digit product format
500905816
Labeler code
50090
Product ID
50090-5816_0e46ee76-c28b-4c24-83e7-4925a293fa05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208412
Marketing category
ANDA
Marketing start
2021-09-01
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

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-5816-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5816-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-5816-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-5816-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-5816-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-5816-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-5816-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-5816-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-5816-60efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-5816-6ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-5816-6367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 141 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11c2088c7a36db…
2026-10-15 13:18:302026-09A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11c2088c7a36db…
2026-10-15 13:18:302026-09A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11c2088c7a36db…
2026-10-15 13:18:302026-09A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20c2088c7a36db…
2026-10-15 13:18:302026-09A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20c2088c7a36db…
2026-09-14 22:38:342026-08A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-1184e616aacf4f…
2026-09-14 22:38:342026-08A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-2084e616aacf4f…
2026-09-14 22:38:342026-08A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-2084e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 141 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A208412-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A208412-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A208412-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A208412-004AB1c2088c7a36db…
2026-10-15 13:18:302026-09A208412-005AB1c2088c7a36db…
2026-09-14 22:38:342026-08A208412-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208412-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208412-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A208412-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A208412-005AB184e616aacf4f…
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…

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE5 mg/1

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-07PredniSONE Tablets USP Rx only
2023-02-07PredniSONE Tablets USP Rx only
2023-01-30PredniSONE Tablets USP Rx only
2023-01-30PredniSONE Tablets USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5816-6EA - Each50090-581642fbb05d-a692-4ec3-b9b4-6f39dff780eb12022-03-09

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 2 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
prednisonePREDNISONESportpharm LLC0e3d2f62-2b02-4ddf-a983-abb71ff31e362026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONECoupler LLC47bb25d2-f33c-96ce-e063-6394a90a069e2026-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONENorthwind Health Company, LLCf2f1a2ea-fa1b-b4f1-e053-2995a90aa2762026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONENorthwind Health Company, LLCf7e523ab-d831-6acf-e053-6294a90a79a32026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONENorthwind Health Company, LLCfc4cd6f4-e01f-ad2d-e053-6294a90aebd62026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEStrides Pharma Science Limited2ef05381-faad-4e0f-b58d-9f2236a04a2c2025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEStrides Pharma Science Limited52010a34-aadb-4561-ac4a-3ee53f5e35662025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
PrednisonePREDNISONEDirect_Rx24882e23-c05f-f2ee-e063-6294a90a536f2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONECoupler LLC3e0e3e28-e6ff-7b48-e063-6294a90a9acd2025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEAdvanced Rx of Tennessee, LLC2d0562ad-6175-833c-e063-6394a90ad0292025-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEProficient Rx LPc2f477da-0b99-4fc4-89ca-94831de950a32025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEBryant Ranch Prepack9a2d3bee-610b-44dc-8266-869aaf08f0d12025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEBryant Ranch Prepackf0354431-4968-4e34-969b-6985d73700a42025-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEA-S Medication Solutions1cb252f0-fd01-4620-bf88-2108fc1ea6152025-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
PrednisonePREDNISONEDirect_Rxfd8eb82e-52df-c368-e053-6294a90ac6b02025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEA-S Medication Solutions90b8b43e-01f9-4503-91c4-2b3cbae91a832024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEA-S Medication Solutionsf4cc64f8-781f-437a-a4a7-2d163026d1c22024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEBryant Ranch Prepack4433a882-ff79-4a9d-8db8-1977c5cd04cf2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5816-65009058160690 TABLET in 1 BOTTLE (50090-5816-6) 90 tablet2021-10-180000-00-00NoNoCurrent