PREDNISONE

Product NDC
60760-615
11-digit product format
607600615
Labeler code
60760
Product ID
60760-615_b403e752-6d49-128f-e053-2a95a90aa153
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA210525
Marketing category
ANDA
Marketing start
2020-11-05
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60760-615DDiscontinued by firm2026-10-12
excluded packagepackage60760-61560760-615-18DDiscontinued by firm2026-10-12

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 · 4 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 packagepackage60760-615-18d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60760-615-18f5e01cc5f278…a2eaf40c39c3…

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

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
A210525-001PREDNISONEPREDNISONE10MGTABLET / ORAL2018-12-04
A210525-002PREDNISONEPREDNISONE20MGTABLET / ORAL2018-12-04
A210525-003PREDNISONEPREDNISONE50MGTABLET / ORAL2018-12-04
A210525-004PREDNISONEPREDNISONE2.5MGTABLET / ORAL2018-12-07
A210525-005PREDNISONEPREDNISONE5MGTABLET / ORAL2018-12-07

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 5 · 173 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210525-001PREDNISONE10MGTABLET / ORAL2018-12-0484e616aacf4f…
2026-09-14 22:38:342026-08A210525-002PREDNISONE20MGTABLET / ORAL2018-12-0484e616aacf4f…
2026-09-14 22:38:342026-08A210525-003PREDNISONE50MGTABLET / ORAL2018-12-0484e616aacf4f…
2026-09-14 22:38:342026-08A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-0784e616aacf4f…
2026-09-14 22:38:342026-08A210525-005PREDNISONE5MGTABLET / ORAL2018-12-0784e616aacf4f…
2026-08-18 06:07:402026-07A210525-001PREDNISONE10MGTABLET / ORAL2018-12-04caaa826d4ba7…
2026-08-18 06:07:402026-07A210525-002PREDNISONE20MGTABLET / ORAL2018-12-04caaa826d4ba7…
2026-08-18 06:07:402026-07A210525-003PREDNISONE50MGTABLET / ORAL2018-12-04caaa826d4ba7…
2026-08-18 06:07:402026-07A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-07caaa826d4ba7…
2026-08-18 06:07:402026-07A210525-005PREDNISONE5MGTABLET / ORAL2018-12-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210525-001PREDNISONE10MGTABLET / ORAL2018-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210525-002PREDNISONE20MGTABLET / ORAL2018-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210525-003PREDNISONE50MGTABLET / ORAL2018-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210525-005PREDNISONE5MGTABLET / ORAL2018-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-001PREDNISONE10MGTABLET / ORAL2018-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-002PREDNISONE20MGTABLET / ORAL2018-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-003PREDNISONE50MGTABLET / ORAL2018-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-005PREDNISONE5MGTABLET / ORAL2018-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210525-001PREDNISONE10MGTABLET / ORAL2018-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210525-002PREDNISONE20MGTABLET / ORAL2018-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210525-003PREDNISONE50MGTABLET / ORAL2018-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210525-005PREDNISONE5MGTABLET / ORAL2018-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-001PREDNISONE10MGTABLET / ORAL2018-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-002PREDNISONE20MGTABLET / ORAL2018-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-003PREDNISONE50MGTABLET / ORAL2018-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-005PREDNISONE5MGTABLET / ORAL2018-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-001PREDNISONE10MGTABLET / ORAL2018-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-002PREDNISONE20MGTABLET / ORAL2018-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-003PREDNISONE50MGTABLET / ORAL2018-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-005PREDNISONE5MGTABLET / ORAL2018-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-001PREDNISONE10MGTABLET / ORAL2018-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-002PREDNISONE20MGTABLET / ORAL2018-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-003PREDNISONE50MGTABLET / ORAL2018-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-005PREDNISONE5MGTABLET / ORAL2018-12-0703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-02-18 07:12 UTC2024-02A210525-005AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210525-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A210525-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A210525-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A210525-004AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A210525-005AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210525-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210525-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210525-003AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210525-004AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210525-005AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210525-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210525-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210525-003AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210525-004AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210525-005AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210525-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210525-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210525-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210525-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210525-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210525-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210525-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A210525-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A210525-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210525-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A210525-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A210525-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210525-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210525-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210525-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210525-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A210525-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A210525-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210525-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A210525-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A210525-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210525-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210525-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210525-003AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-615PREDNISONE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Legacy NDC20201117_b403e258-34d7-f69e-e053-2a95a90ac185.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-615-186076006151818 TABLET in 1 BOTTLE, PLASTIC (60760-615-18) 18 tablet2020-11-050000-00-00NoNoCurrent