Prednisone

Product NDC
43063-866
11-digit product format
430630866
Labeler code
43063
Product ID
43063-866_da2e690c-8f3c-80ea-e053-2a95a90ac2b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040362
Marketing category
ANDA
Marketing start
2001-08-29
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 12 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43063-866DDiscontinued by firm2026-08-03
excluded packagepackage43063-86643063-866-07DDiscontinued by firm2026-08-03
excluded packagepackage43063-86643063-866-10DDiscontinued by firm2026-08-03
excluded packagepackage43063-86643063-866-12DDiscontinued by firm2026-08-03
excluded packagepackage43063-86643063-866-20DDiscontinued by firm2026-08-03
excluded packagepackage43063-86643063-866-21DDiscontinued by firm2026-08-03
excluded packagepackage43063-86643063-866-28DDiscontinued by firm2026-08-03
excluded packagepackage43063-86643063-866-30DDiscontinued by firm2026-08-03
excluded packagepackage43063-86643063-866-40DDiscontinued by firm2026-08-03
excluded packagepackage43063-86643063-866-42DDiscontinued by firm2026-08-03
excluded packagepackage43063-86643063-866-50DDiscontinued by firm2026-08-03
excluded packagepackage43063-86643063-866-60DDiscontinued by firm2026-08-03

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

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
A040362-001PREDNISONEPREDNISONE10MGTABLET / ORALAB2001-08-29
A040362-002PREDNISONEPREDNISONE5MGTABLET / ORALAB2001-08-29
A040362-003PREDNISONEPREDNISONE20MGTABLET / ORALAB2005-06-29
A040362-004PREDNISONEPREDNISONE2.5MGTABLET / ORALAB2023-04-17
A040362-005PREDNISONEPREDNISONE50MGTABLET / ORALAB2023-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A040362-001AB
A040362-002AB
A040362-003AB
A040362-004AB
A040362-005AB

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 5 · 167 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-175bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 167 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040362-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040362-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-005AB15bbf6a4d5a75…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-866-07EA - Each43063-8668e8ffb29-215e-4ff3-8a44-cdbfbbe10f2712022-05-04
43063-866-10EA - Each43063-866086b8957-b6c9-4594-85d1-476f25540d8d12018-08-13
43063-866-12EA - Each43063-866ee92c597-65d0-478b-8904-fd4743c8689b12019-02-13
43063-866-20EA - Each43063-8661e819328-1f97-4cce-80c2-3cff1e41b1fa12018-08-13
43063-866-21EA - Each43063-8661155cd1c-7da9-4b38-95f6-5b413b22528812018-09-05
43063-866-28EA - Each43063-8665d24df3c-86d8-4965-a7d1-b35c6b144fd212019-05-02
43063-866-30EA - Each43063-866741908bf-ff30-4566-a842-7077b4131ee912018-09-05
43063-866-40EA - Each43063-86672eac73b-6997-4617-8680-7c1fa6e8adab12018-09-05
43063-866-42EA - Each43063-8661d89a556-489a-42d7-aa97-63930c13336212018-08-13
43063-866-50EA - Each43063-866b5a20387-0f9f-4ea7-88d7-afbd23c674d812018-12-13
43063-866-60EA - Each43063-866fb7e9f8f-cc2d-47fc-87b0-7ccb1c22158412019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-866PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.]25Legacy NDC20240820_25621933-804e-4181-8524-d60f72969e55.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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEA-S Medication Solutions74102cc5-7a1a-4a0f-a07f-a4b0f86bcabf2025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEA-S Medication Solutionsdc94273f-af06-4bd5-9ce3-ce0a0f36587b2025-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAdvanced Rx of Tennessee, LLCaf863b9e-964b-3b1e-e053-2995a90ab93a2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAdvanced Rx Pharmacy of Tennessee, LLCb3dbf833-b929-8c85-e053-2995a90a58962024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAdvanced Rx Pharmacy of Tennessee, LLCe1e7d14b-80b2-f57e-e053-2995a90af1122024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAdvanced Rx Pharmacy of Tennessee, LLCb3dbff9f-610f-7782-e053-2a95a90a71c12024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.62fdf3c2-cfa9-d573-e053-2a91aa0a833b2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.62ec965c-e682-9920-e053-2a91aa0adcdb2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.62ff1da3-79aa-676a-e053-2991aa0a4a9f2024-07-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEA-S Medication Solutions751b7f62-f92b-4b7c-a588-2c882d5d1ce32024-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEA-S Medication Solutionscb1b0dc0-6916-4e6f-9775-26ea0f593f832024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.63106192-35d5-6989-e053-2991aa0aa7142024-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEA-S Medication Solutions5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d22024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.63102d75-9b2b-84a9-e053-2a91aa0a317d2024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEProficient Rx LP5961b1d4-6a4c-452f-b3f1-c99f3a9a64452023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAsclemed USA, Inc.dc663fd3-b149-48ae-a3f3-6abaa4808cc62020-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEProficient Rx LPe4555299-af68-416f-8999-9bb703a45e772019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEProficient Rx LP7c650dc8-43f6-4257-81ed-c93b00202d062019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-866-07430630866077 TABLET in 1 BOTTLE, PLASTIC (43063-866-07) 7 tablet2022-03-140000-00-00NoNoCurrent
43063-866-104306308661010 TABLET in 1 BOTTLE, PLASTIC (43063-866-10) 10 tablet2018-07-090000-00-00NoNoCurrent
43063-866-124306308661212 TABLET in 1 BOTTLE, PLASTIC (43063-866-12) 12 tablet2019-01-160000-00-00NoNoCurrent
43063-866-204306308662020 TABLET in 1 BOTTLE, PLASTIC (43063-866-20) 20 tablet2018-07-090000-00-00NoNoCurrent
43063-866-214306308662121 TABLET in 1 BOTTLE, PLASTIC (43063-866-21) 21 tablet2018-08-140000-00-00NoNoCurrent
43063-866-284306308662828 TABLET in 1 BOTTLE, PLASTIC (43063-866-28) 28 tablet2019-03-140000-00-00NoNoCurrent
43063-866-304306308663030 TABLET in 1 BOTTLE, PLASTIC (43063-866-30) 30 tablet2018-07-180000-00-00NoNoCurrent
43063-866-404306308664040 TABLET in 1 BOTTLE, PLASTIC (43063-866-40) 40 tablet2018-08-140000-00-00NoNoCurrent
43063-866-424306308664242 TABLET in 1 BOTTLE, PLASTIC (43063-866-42) 42 tablet2018-07-090000-00-00NoNoCurrent
43063-866-504306308665050 TABLET in 1 BOTTLE, PLASTIC (43063-866-50) 50 tablet2018-10-110000-00-00NoNoCurrent
43063-866-604306308666060 TABLET in 1 BOTTLE, PLASTIC (43063-866-60) 60 tablet2019-01-240000-00-00NoNoCurrent