PREDNISONE

Product NDC
70934-471
11-digit product format
709340471
Labeler code
70934
Product ID
70934-471_a82421b3-2e25-3d9d-e053-2a95a90a46c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA210525
Marketing category
ANDA
Marketing start
2019-12-09
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-471DDiscontinued by firm2026-10-16
excluded packagepackage70934-47170934-471-05DDiscontinued by firm2026-10-16
excluded packagepackage70934-47170934-471-10DDiscontinued by firm2026-10-16
excluded packagepackage70934-47170934-471-12DDiscontinued by firm2026-10-16
excluded packagepackage70934-47170934-471-15DDiscontinued by firm2026-10-16
excluded packagepackage70934-47170934-471-18DDiscontinued by firm2026-10-16
excluded packagepackage70934-47170934-471-20DDiscontinued by firm2026-10-16
excluded packagepackage70934-47170934-471-21DDiscontinued by firm2026-10-16
excluded packagepackage70934-47170934-471-30DDiscontinued by firm2026-10-16
excluded packagepackage70934-47170934-471-40DDiscontinued by firm2026-10-16

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 · 147 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 packagepackage70934-471-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-471-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-471-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-471-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-471-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-471-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-471-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-471-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70934-471-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-471-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-471-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-471-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-471-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-471-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-471-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-471-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-471-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-471-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-471-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-471-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-471-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-471-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-471-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-471-182ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-471-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-471-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-471-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-471-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-471-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-471-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-471-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-471-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-471-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-471-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-471-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-471-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-471-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-471-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-471-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-471-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-471-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-471-18cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-471-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-471-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-471-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-471-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-471-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-471-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-471-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-471-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-471-18cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-471-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-471-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-471-05cdf11ea48f46…ba0047e9e063…

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
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 · 178 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A210525-001PREDNISONE10MGTABLET / ORAL2018-12-04c2088c7a36db…
2026-10-15 13:18:302026-09A210525-002PREDNISONE20MGTABLET / ORAL2018-12-04c2088c7a36db…
2026-10-15 13:18:302026-09A210525-003PREDNISONE50MGTABLET / ORAL2018-12-04c2088c7a36db…
2026-10-15 13:18:302026-09A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-07c2088c7a36db…
2026-10-15 13:18:302026-09A210525-005PREDNISONE5MGTABLET / ORAL2018-12-07c2088c7a36db…
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…

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.

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-471-10EA - Each70934-4712557f684-98eb-4e9d-ad39-96cf92607b4712023-01-09
70934-471-12EA - Each70934-47127d93975-a021-454e-b120-a57fc425887712023-01-09
70934-471-15EA - Each70934-4716aac39d1-928c-4479-9726-1b5b13dca6f112023-01-09
70934-471-20EA - Each70934-471e8d4afa0-dbfa-4b7a-874e-575269708cc912023-01-09
70934-471-21EA - Each70934-471e7f88024-a5ba-40bc-9bd2-ab4d1d68825b12021-11-09
70934-471-30EA - Each70934-471e3a8802c-6940-4327-ad8f-11c7a3cb2bb912023-01-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-471-107093404711010 TABLET in 1 BOTTLE, PLASTIC (70934-471-10) 10 tablet2019-12-300000-00-00NoNoCurrent
70934-471-127093404711212 TABLET in 1 BOTTLE, PLASTIC (70934-471-12) 12 tablet2020-01-090000-00-00NoNoCurrent
70934-471-157093404711515 TABLET in 1 BOTTLE, PLASTIC (70934-471-15) 15 tablet2019-12-300000-00-00NoNoCurrent
70934-471-187093404711818 TABLET in 1 BOTTLE, PLASTIC (70934-471-18) 18 tablet2020-02-120000-00-00NoNoCurrent
70934-471-207093404712020 TABLET in 1 BOTTLE, PLASTIC (70934-471-20) 20 tablet2019-12-090000-00-00NoNoCurrent
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