prednisone

Product NDC
70518-4038
11-digit product format
705184038
Labeler code
70518
Product ID
70518-4038_51b89f74-a606-686e-e063-6294a90a58a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208412
Marketing category
ANDA
Marketing start
2024-03-15
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-403870518-4038-1DDiscontinued by firm2026-10-05
excluded packagepackage70518-403870518-4038-2DDiscontinued by firm2026-10-05
excluded packagepackage70518-403870518-4038-4DDiscontinued by firm2026-10-05

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-403870518-4038-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-403870518-4038-1DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…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
A208412-001PREDNISONEPREDNISONE10MGTABLET / ORALAB2021-02-11
A208412-002PREDNISONEPREDNISONE20MGTABLET / ORALAB2021-02-11
A208412-003PREDNISONEPREDNISONE50MGTABLET / ORALAB2022-01-11
A208412-004PREDNISONEPREDNISONE2.5MGTABLET / ORALAB2020-11-20
A208412-005PREDNISONEPREDNISONE5MGTABLET / ORALAB2020-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208412-001AB
A208412-002AB
A208412-003AB
A208412-004AB
A208412-005AB

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 4 · 136 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-1184e616aacf4f…
2026-09-14 22:38:342026-08A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-1184e616aacf4f…
2026-09-14 22:38:342026-08A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-2084e616aacf4f…
2026-09-14 22:38:342026-08A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-2084e616aacf4f…
2026-08-18 06:07:402026-07A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-2003ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208412-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208412-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208412-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A208412-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A208412-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A208412-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208412-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208412-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-005AB103ed91905a0d…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
prednisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VB0R961HZTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198145Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b3b70d6f-dc44-4a54-b39b-2762f37d5575Available on FDA.report

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
70518-4038-0prednisone48 in 1 BOTTLE, PLASTICTABLET4811
70518-4038-1prednisone15 in 1 BOTTLE, PLASTICTABLET1511
70518-4038-2prednisone18 in 1 BOTTLE, PLASTICTABLET1811
70518-4038-3prednisone10 in 1 BOTTLE, PLASTICTABLET1011
70518-4038-4prednisone30 in 1 BLISTER PACKTABLET3011
70518-4038-5prednisone20 in 1 BOTTLE, PLASTICTABLET2011
70518-4038-6prednisone14 in 1 BOTTLE, PLASTICTABLET1411
70518-4038-7prednisone21 in 1 BOTTLE, PLASTICTABLET2111
70518-4038-8prednisone20 in 1 BOTTLE, PLASTICTABLET2011
70518-4038-9prednisone100 in 1 BOTTLE, PLASTICTABLET10011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4038PREDNISONE TABLET [REMEDYREPACK INC.]6Current NDC, 10 package rows20250406_b3b70d6f-dc44-4a54-b39b-2762f37d5575.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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
prednisonePREDNISONEREMEDYREPACK INC.23b12d22-97d6-426e-bf9c-dd6c2ff773702026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEPreferred Pharmaceuticals Inc.1e74ac55-4a48-4bf5-bfed-36c0fa37dd9f2026-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEPreferred Pharmaceuticals Inc.ce7663a7-4c91-4790-aa43-96f259b3bb182026-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.af5d0f73-2aef-4db1-ae25-6d465c9f0ca12026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.5218e88b-468b-4d60-ab7e-78cca632b23a2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
PrednisonePREDNISONECardinal Health 107, LLCcdc2b903-5d86-45c1-b97c-2da48445dbdd2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONESt. Mary's Medical Park Pharmacye4437eec-eadf-7c8b-e053-2a95a90af8462026-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONECoupler LLC53864d75-06ca-5c2a-e063-6394a90ad9662026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEBryant Ranch Prepackecc48869-3812-4440-a398-749b280620592026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEAmerican Health Packagingfdcd49a6-6cb1-49f8-9f4c-feb475c129b32026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONECardinal Health 107, LLC1d797f3e-a46c-42bc-91bb-c570ae8ca8c22026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.ea4070e1-080d-4feb-9561-3910c6b712dd2026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.b3b70d6f-dc44-4a54-b39b-2762f37d55752026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
ndc (product): 70518-4038
prednisonePREDNISONEQPharma Inc11870c93-fe64-e6c9-e063-6394a90a53342026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEQPharma Incf795ea1d-f41a-6100-e053-6394a90a63a42026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
PrednisonePREDNISONEDirect_Rxf6051257-2144-4487-e053-2995a90a973b2026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEBryant Ranch Prepackfbfd4e2b-3c8f-43c8-bcbe-da1ac4be75c52026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEProficient Rx LP4b37ada5-1f22-46d5-a794-fd1477c0eb9b2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONESportpharm LLC5dde7256-d3b8-400d-a0eb-c60078bfc5d92026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.e9a74862-6a3b-4247-837a-389761b5c3522026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNb3b70d6f-dc44-4a54-b39b-2762f37d557511
198145prednisone 10 MG Oral TabletSCDb3b70d6f-dc44-4a54-b39b-2762f37d557511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4038-07051840380048 TABLET in 1 BOTTLE, PLASTIC (70518-4038-0) 48 tablet2024-03-15NoNoCurrent
70518-4038-17051840380115 in 1 BOTTLE, PLASTICHistorical
70518-4038-27051840380218 in 1 BOTTLE, PLASTICHistorical
70518-4038-37051840380310 TABLET in 1 BOTTLE, PLASTIC (70518-4038-3) 10 tablet2024-04-16NoNoCurrent
70518-4038-47051840380430 in 1 BLISTER PACKHistorical
70518-4038-57051840380520 TABLET in 1 BOTTLE, PLASTIC (70518-4038-5) 20 tablet2025-03-25NoNoCurrent
70518-4038-67051840380614 TABLET in 1 BOTTLE, PLASTIC (70518-4038-6) 14 tablet2025-04-03NoNoCurrent
70518-4038-77051840380721 TABLET in 1 BOTTLE, PLASTIC (70518-4038-7) 21 tablet2026-02-11NoNoCurrent
70518-4038-87051840380820 TABLET in 1 BOTTLE, PLASTIC (70518-4038-8) 20 tablet2026-04-03NoNoCurrent
70518-4038-970518403809100 TABLET in 1 BOTTLE, PLASTIC (70518-4038-9) 100 tablet2026-05-13NoNoCurrent