Prednisone

Product NDC
51655-320
11-digit product format
516550320
Labeler code
51655
Product ID
51655-320_b9bb8a5e-0706-459f-917c-77e8fcacffa2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA088832
Marketing category
ANDA
Marketing start
2014-04-29
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 mg/201
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51655-320DDiscontinued by firm2026-08-17
excluded productproduct51655-320DDiscontinued by firm2026-08-17
excluded packagepackage51655-32051655-320-20DDiscontinued by firm2026-08-17
excluded packagepackage51655-32051655-320-18DDiscontinued by firm2026-08-17
excluded packagepackage51655-32051655-320-21DDiscontinued by firm2026-08-17
excluded packagepackage51655-32051655-320-30DDiscontinued by firm2026-08-17
excluded packagepackage51655-32051655-320-53DDiscontinued by firm2026-08-17
excluded packagepackage51655-32051655-320-54DDiscontinued by firm2026-08-17

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 3 · 176 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-320-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-320-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-320-54d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-320-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-320-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-320-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-320-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-320-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-320-54f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-320-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-320-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-320-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-320-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-320-182ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-320-542ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-320-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-320-532ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-320-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-320-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-320-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-320-54a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-320-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-320-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-320-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-320-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-320-18cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-320-54cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-320-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-320-53cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-320-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-320-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-320-18cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-320-54cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-320-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-320-53cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-320-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-320-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-320-18302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-320-54302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-320-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-320-53302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-320-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-320-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-320-18ed331223b511…672a5bd82f5f…

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
2025-08-23 18:47 UTC2025-08A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-043f01610625f2…
2019-09-15 20:21 UTC2019-09A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A088832-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088832-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088832-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088832-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088832-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088832-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088832-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088832-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088832-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088832-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088832-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088832-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088832-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088832-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088832-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088832-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088832-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088832-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088832-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A088832-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088832-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088832-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088832-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A088832-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088832-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088832-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088832-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088832-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088832-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088832-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088832-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088832-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088832-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088832-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088832-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088832-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088832-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088832-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [NORTHWIND PHARMACEUTICALS]4
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [NORTHWIND PHARMACEUTICALS]4
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [NORTHWIND PHARMACEUTICALS]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-320PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS]4Legacy NDC20150122_2a994060-a358-4835-892b-0eb1f0806eb0.zip
51655-320PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140501_c7acd116-7bda-4976-9f5f-cd5e7ddc0d02.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONENorthwind Health Company, LLCf76db82a-826e-92b0-e053-6294a90a8ec62026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088832
application number: ANDA088832
PrednisonePREDNISONEGolden State Medical Supply, Inc.1e05e071-0407-0970-e063-6294a90a6c652025-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088832
application number: ANDA088832
PrednisonePREDNISONEMylan Pharmaceuticals Inc.fec09050-5ac2-451b-a2b9-5a21b2def2122024-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088832
application number: ANDA088832