prednisone

Product NDC
50090-7218
11-digit product format
500907218
Labeler code
50090
Product ID
50090-7218_854dd790-2b3d-4b8a-bd1d-2ea112c6a01c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208412
Marketing category
ANDA
Marketing start
2021-09-01
Substance
PREDNISONE
Active strength
10 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 131 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-202680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 131 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-005AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
prednisone
Listing expiration
2026-12-31

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
f4cc64f8-781f-437a-a4a7-2d163026d1c2Available 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
50090-7218-0prednisone10 in 1 BOTTLETABLET104
50090-7218-1prednisone15 in 1 BOTTLETABLET154
50090-7218-2prednisone21 in 1 BOTTLETABLET214
50090-7218-4prednisone50 in 1 BOTTLETABLET504
50090-7218-5prednisone30 in 1 BOTTLETABLET304
50090-7218-7prednisone100 in 1 BOTTLETABLET1004
50090-7218-8prednisone40 in 1 BOTTLETABLET404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7218-0EA - Each50090-7218d21d8a34-ea56-49df-8853-9a27486de3a112024-09-09
50090-7218-1EA - Each50090-721818c44860-9137-4a4c-a503-dc9c9565fa2312024-09-09
50090-7218-2EA - Each50090-72187b0f0e4f-0fb6-47f4-80b7-e831d9759d6312024-09-09
50090-7218-4EA - Each50090-72180e2f0f72-e4ae-4115-9c2c-c533bf72f57012024-09-09
50090-7218-5EA - Each50090-721895b3eb57-0724-4848-a688-7e245fa6e5d412024-09-09
50090-7218-7EA - Each50090-7218bcb77984-f393-48f2-9b4c-0a5b746a317f12024-09-09
50090-7218-8EA - Each50090-72183bd95125-7037-4083-b85a-4724ca7c7e0a12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7218PREDNISONE TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, 7 package rows20240816_f4cc64f8-781f-437a-a4a7-2d163026d1c2.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.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
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
prednisonePREDNISONEREMEDYREPACK INC.b540f4af-8f07-4c56-b151-d759440c514a2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEBryant Ranch Prepack70d05ed7-5c4e-4cd1-84cd-0dbe90692c542026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEAsclemed USA, Inc.fdcf3271-fae7-47ef-a370-adbdc0a3cf372026-03-03Warnings, 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 TabletPSNf4cc64f8-781f-437a-a4a7-2d163026d1c24
198145prednisone 10 MG Oral TabletSCDf4cc64f8-781f-437a-a4a7-2d163026d1c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7218-05009072180010 TABLET in 1 BOTTLE (50090-7218-0) 10 tablet2024-08-13NoNoCurrent
50090-7218-15009072180115 TABLET in 1 BOTTLE (50090-7218-1) 15 tablet2024-08-13NoNoCurrent
50090-7218-25009072180221 TABLET in 1 BOTTLE (50090-7218-2) 21 tablet2024-08-13NoNoCurrent
50090-7218-45009072180450 TABLET in 1 BOTTLE (50090-7218-4) 50 tablet2024-08-13NoNoCurrent
50090-7218-55009072180530 TABLET in 1 BOTTLE (50090-7218-5) 30 tablet2024-08-13NoNoCurrent
50090-7218-750090721807100 TABLET in 1 BOTTLE (50090-7218-7) 100 tablet2024-08-13NoNoCurrent
50090-7218-85009072180840 TABLET in 1 BOTTLE (50090-7218-8) 40 tablet2024-08-13NoNoCurrent