Prednisone

Product NDC
71335-0508
Requested package NDC
71335-0508-9
11-digit product format
713350508
Labeler code
71335
Product ID
71335-0508_1d5b8df8-e31d-4c84-ab41-46c718ebb027
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040362
Marketing category
ANDA
Marketing start
2001-08-29
Substance
PREDNISONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-050871335-0508-9DDiscontinued 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0508-0Prednisone42 in 1 BOTTLETABLET4215
71335-0508-1Prednisone30 in 1 BOTTLETABLET3015
71335-0508-2Prednisone78 in 1 BOTTLETABLET7815
71335-0508-3Prednisone36 in 1 BOTTLETABLET3615
71335-0508-4Prednisone21 in 1 BOTTLETABLET2115
71335-0508-5Prednisone15 in 1 BOTTLETABLET1515
71335-0508-6Prednisone100 in 1 BOTTLETABLET10015
71335-0508-7Prednisone20 in 1 BOTTLETABLET2015
71335-0508-8Prednisone10 in 1 BOTTLETABLET1015
71335-0508-9Prednisone90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0508-0EA - Each71335-0508a543f02b-af67-4bbe-8171-8e9fc9dcf3fc12018-03-08
71335-0508-1EA - Each71335-0508cdc39a81-7be2-412d-9089-2156a75efc4012018-03-08
71335-0508-2EA - Each71335-05085a3cc7af-8c2e-4097-a38d-67140cbc845412018-03-08
71335-0508-3EA - Each71335-05083792c138-c8cc-49aa-ba4b-06b3c8519b5512018-03-08
71335-0508-4EA - Each71335-05082a332326-4cad-48fe-9f46-a4916df3b7a612018-03-08
71335-0508-5EA - Each71335-0508d72b0ef1-432f-4651-a502-bd683f652b3512018-03-08
71335-0508-6EA - Each71335-05080fafc72e-0d2e-415c-869a-da6d450aa17d12018-03-08
71335-0508-7EA - Each71335-0508e6843049-598a-44cd-9584-a83368ea0a6012018-03-08
71335-0508-8EA - Each71335-05080d051bd2-790d-43d5-9d21-6aa67a28960012018-03-08
71335-0508-9EA - Each71335-0508b6305a24-38a2-464d-b0b0-930879e7ac0412018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0508PREDNISONE (PREDNISONE) TABLET [BRYANT RANCH PREPACK]15Current NDC, Legacy NDC, 10 package rows20240809_70003b50-1802-436d-9bee-3e2e4858e461.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN70003b50-1802-436d-9bee-3e2e4858e46115
312615predniSONE 20 MG Oral TabletPSN70003b50-1802-436d-9bee-3e2e4858e46115
312617predniSONE 5 MG Oral TabletPSN70003b50-1802-436d-9bee-3e2e4858e46115
198145prednisone 10 MG Oral TabletSCD70003b50-1802-436d-9bee-3e2e4858e46115
312615prednisone 20 MG Oral TabletSCD70003b50-1802-436d-9bee-3e2e4858e46115
312617prednisone 5 MG Oral TabletSCD70003b50-1802-436d-9bee-3e2e4858e46115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0508-97133505080990 TABLET in 1 BOTTLE (71335-0508-9) 90 tablet2015-02-190000-00-00NoNoCurrent