Prednisone

Product NDC
10135-777
11-digit product format
101350777
Labeler code
10135
Product ID
10135-777_441fcae7-8682-1a29-e063-6394a90a3881
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA211575
Marketing category
ANDA
Marketing start
2023-02-01
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
A211575-001PREDNISONEPREDNISONE2.5MGTABLET / ORALAB2019-11-15
A211575-002PREDNISONEPREDNISONE5MGTABLET / ORALAB2019-11-15
A211575-003PREDNISONEPREDNISONE10MGTABLET / ORALAB2019-11-15
A211575-004PREDNISONEPREDNISONE20MGTABLET / ORALAB2019-11-15
A211575-005PREDNISONEPREDNISONE50MGTABLET / ORALAB2019-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211575-001AB
A211575-002AB
A211575-003AB
A211575-004AB
A211575-005AB

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 · 195 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211575-001PREDNISONE2.5MGTABLET / ORALAB2019-11-15caaa826d4ba7…
2026-08-18 06:07:402026-07A211575-002PREDNISONE5MGTABLET / ORALAB2019-11-15caaa826d4ba7…
2026-08-18 06:07:402026-07A211575-003PREDNISONE10MGTABLET / ORALAB2019-11-15caaa826d4ba7…
2026-08-18 06:07:402026-07A211575-004PREDNISONE20MGTABLET / ORALAB2019-11-15caaa826d4ba7…
2026-08-18 06:07:402026-07A211575-005PREDNISONE50MGTABLET / ORALAB2019-11-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211575-001PREDNISONE2.5MGTABLET / ORALAB2019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211575-002PREDNISONE5MGTABLET / ORALAB2019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211575-003PREDNISONE10MGTABLET / ORALAB2019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211575-004PREDNISONE20MGTABLET / ORALAB2019-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211575-005PREDNISONE50MGTABLET / ORALAB2019-11-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211575-001PREDNISONE2.5MGTABLET / ORALAB2019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211575-002PREDNISONE5MGTABLET / ORALAB2019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211575-003PREDNISONE10MGTABLET / ORALAB2019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211575-004PREDNISONE20MGTABLET / ORALAB2019-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211575-005PREDNISONE50MGTABLET / ORALAB2019-11-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A211575-001PREDNISONE2.5MGTABLET / ORALAB2019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211575-002PREDNISONE5MGTABLET / ORALAB2019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211575-003PREDNISONE10MGTABLET / ORALAB2019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211575-004PREDNISONE20MGTABLET / ORALAB2019-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211575-005PREDNISONE50MGTABLET / ORALAB2019-11-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211575-001PREDNISONE2.5MGTABLET / ORALAB2019-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211575-002PREDNISONE5MGTABLET / ORALAB2019-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211575-003PREDNISONE10MGTABLET / ORALAB2019-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211575-004PREDNISONE20MGTABLET / ORALAB2019-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211575-005PREDNISONE50MGTABLET / ORALAB2019-11-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211575-001PREDNISONE2.5MGTABLET / ORALAB2019-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211575-002PREDNISONE5MGTABLET / ORALAB2019-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211575-003PREDNISONE10MGTABLET / ORALAB2019-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211575-004PREDNISONE20MGTABLET / ORALAB2019-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211575-005PREDNISONE50MGTABLET / ORALAB2019-11-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211575-001PREDNISONE2.5MGTABLET / ORALAB2019-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211575-002PREDNISONE5MGTABLET / ORALAB2019-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211575-003PREDNISONE10MGTABLET / ORALAB2019-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211575-004PREDNISONE20MGTABLET / ORALAB2019-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211575-005PREDNISONE50MGTABLET / ORALAB2019-11-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211575-001PREDNISONE2.5MGTABLET / ORALAB2019-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211575-002PREDNISONE5MGTABLET / ORALAB2019-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211575-003PREDNISONE10MGTABLET / ORALAB2019-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211575-004PREDNISONE20MGTABLET / ORALAB2019-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211575-005PREDNISONE50MGTABLET / ORALAB2019-11-152680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 195 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211575-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211575-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211575-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211575-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211575-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211575-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211575-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211575-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211575-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211575-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211575-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211575-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211575-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211575-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211575-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211575-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211575-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211575-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211575-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211575-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211575-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211575-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211575-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211575-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211575-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211575-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211575-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211575-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211575-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211575-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211575-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211575-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211575-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211575-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211575-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211575-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211575-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211575-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211575-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211575-005AB12680178bc6a6…

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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198145Internal RxNorm lookup
198146Internal RxNorm lookup
198148Internal RxNorm lookup
312615Internal RxNorm lookup
312617Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f499197b-b9b7-1707-e053-2a95a90a0932Available 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
10135-777-01Prednisone100 in 1 BOTTLETABLET1003
10135-777-10Prednisone1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-777-01EA - Each10135-77722f791e0-f640-440a-aa56-945b5ea40bf212023-04-07
10135-777-10EA - Each10135-7777b949a63-cb89-467e-8fed-de36e916cba512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-777PREDNISONE TABLET [MARLEX PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20241018_f499197b-b9b7-1707-e053-2a95a90a0932.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.19fdbf9f-3a64-b9fa-e063-6394a90af0862026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.1a9f00ac-ec92-4d2c-e063-6394a90ac4f62026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.25b5958b-c151-9200-e063-6394a90af52c2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.1349a022-639b-4494-99a2-1594c7c0f0e92026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONEANI Pharmaceuticals, Inc.f05eb734-07e7-491c-b2e9-aae340e037502026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONESt. Mary's Medical Park Pharmacy1b3ea4cc-5bc6-ae47-e063-6294a90af13d2026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONEAphena Pharma Solutions - Tennessee, LLC18818282-68aa-82e9-e063-6394a90aef542026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
Prednisone D/PPREDNISONE D/PDirect_Rx4f0a3946-025c-798a-e063-6294a90a831b2026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONENorthwind Health Company, LLCfbd3f0c3-06b3-c9b4-e053-6294a90a6fdd2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONEMarlex Pharmaceuticals, Inc.f499197b-b9b7-1707-e053-2a95a90a09322025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
ndc (product): 10135-777
PrednisonePREDNISONEProficient Rx LP08973b30-8576-4d31-aeef-934b72124e1f2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONEAdvanced Rx of Tennessee, LLC30956dd5-fe19-d5a9-e063-6394a90a25492025-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONENuCare Pharmaceuticals, Inc.31cfc21f-726b-ae80-e063-6294a90a9af42025-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONEBryant Ranch Prepackc60a07f9-ed9f-4434-a69d-2e2fea4843fd2025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONEBryant Ranch Prepack7ea7f6a9-78ef-42fe-baac-f817da3976fb2025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.1b42449a-2be8-e4fb-e063-6394a90aff982024-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.1c33879e-8b2b-5843-e063-6294a90adea42024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONEA-S Medication Solutions8f7a38c7-7bf9-4951-b529-947cc9a57d6a2024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONEProficient Rx LP71d70ec6-859a-4951-af98-248a864e11352022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575
PrednisonePREDNISONEProficient Rx LP67681e4e-3002-4428-af5e-6ff1a950b0372022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211575
application number: ANDA211575

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
198146predniSONE 2.5 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
312615predniSONE 20 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
312617predniSONE 5 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
198148predniSONE 50 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
198145prednisone 10 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
198146prednisone 2.5 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
312615prednisone 20 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
312617prednisone 5 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
198148prednisone 50 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10135-777-0110135077701100 TABLET in 1 BOTTLE (10135-777-01) 100 tablet2023-02-01NoNoCurrent
10135-777-10101350777101000 TABLET in 1 BOTTLE (10135-777-10) 1000 tablet2023-02-01NoNoCurrent