Prednisone

Product NDC
71205-421
11-digit product format
712050421
Labeler code
71205
Product ID
71205-421_8a428fc8-6e40-47cc-abc6-602c3aeb6bc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211575
Marketing category
ANDA
Marketing start
2019-11-15
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 · 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
71d70ec6-859a-4951-af98-248a864e1135Available 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
71205-421-10Prednisone10 in 1 BOTTLETABLET109
71205-421-18Prednisone18 in 1 BOTTLETABLET189
71205-421-20Prednisone20 in 1 BOTTLETABLET209
71205-421-21Prednisone21 in 1 BOTTLETABLET219
71205-421-24Prednisone24 in 1 BOTTLETABLET249
71205-421-28Prednisone28 in 1 BOTTLETABLET289
71205-421-30Prednisone30 in 1 BOTTLETABLET309
71205-421-40Prednisone40 in 1 BOTTLETABLET409
71205-421-42Prednisone42 in 1 BOTTLETABLET429
71205-421-60Prednisone60 in 1 BOTTLETABLET609
71205-421-63Prednisone63 in 1 BOTTLETABLET639
71205-421-90Prednisone90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-421-10EA - Each71205-4219fe95e7c-d27a-4096-b0bd-1d41b1b03bf312020-05-08
71205-421-18EA - Each71205-4210649a933-23b9-433f-9ec9-0fb7c5d2653112020-08-06
71205-421-20EA - Each71205-421eecdf175-86c8-4357-afd5-e228e7924e0512022-03-09
71205-421-21EA - Each71205-421049e15f7-bf50-4776-8b85-90046c433d4a12021-10-08
71205-421-24EA - Each71205-421eee92ba2-7ce3-412e-a436-4b17cb8992ec12022-05-04
71205-421-28EA - Each71205-421032dab4c-46f0-4f8a-8a0b-d98f903959af12022-03-09
71205-421-30EA - Each71205-4212293e9b5-7bff-474f-a839-afb4043b0a1a12020-08-06
71205-421-63EA - Each71205-42112aa4a62-56de-417a-977e-9cec5488496d12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-421PREDNISONE TABLET [PROFICIENT RX LP]9Current NDC, Legacy NDC, 12 package rows20220919_71d70ec6-859a-4951-af98-248a864e1135.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
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
ndc (product): 71205-421
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 TabletPSN71d70ec6-859a-4951-af98-248a864e11359
198145prednisone 10 MG Oral TabletSCD71d70ec6-859a-4951-af98-248a864e11359

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-421-107120504211010 TABLET in 1 BOTTLE (71205-421-10) 10 tablet2020-03-100000-00-00NoNoCurrent
71205-421-187120504211818 TABLET in 1 BOTTLE (71205-421-18) 18 tablet2020-06-100000-00-00NoNoCurrent
71205-421-207120504212020 TABLET in 1 BOTTLE (71205-421-20) 20 tablet2020-03-100000-00-00NoNoCurrent
71205-421-217120504212121 TABLET in 1 BOTTLE (71205-421-21) 21 tablet2021-06-230000-00-00NoNoCurrent
71205-421-247120504212424 TABLET in 1 BOTTLE (71205-421-24) 24 tablet2022-01-190000-00-00NoNoCurrent
71205-421-287120504212828 TABLET in 1 BOTTLE (71205-421-28) 28 tablet2021-11-190000-00-00NoNoCurrent
71205-421-307120504213030 TABLET in 1 BOTTLE (71205-421-30) 30 tablet2020-03-100000-00-00NoNoCurrent
71205-421-407120504214040 TABLET in 1 BOTTLE (71205-421-40) 40 tablet2020-06-120000-00-00NoNoCurrent
71205-421-427120504214242 TABLET in 1 BOTTLE (71205-421-42) 42 tablet2020-08-250000-00-00NoNoCurrent
71205-421-607120504216060 TABLET in 1 BOTTLE (71205-421-60) 60 tablet2020-03-100000-00-00NoNoCurrent
71205-421-637120504216363 TABLET in 1 BOTTLE (71205-421-63) 63 tablet2022-09-140000-00-00NoNoCurrent
71205-421-907120504219090 TABLET in 1 BOTTLE (71205-421-90) 90 tablet2020-03-100000-00-00NoNoCurrent