prednisone

Product NDC
60219-1708
11-digit product format
602191708
Labeler code
60219
Product ID
60219-1708_8a3eba28-c6c2-4937-a75f-dc4b737002cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA213386
Marketing category
ANDA
Marketing start
2020-06-24
Substance
PREDNISONE
Active strength
20 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213386-001PREDNISONEPREDNISONE10MGTABLET / ORALAB2020-06-24
A213386-002PREDNISONEPREDNISONE20MGTABLET / ORALAB2020-06-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A213386-001AB
A213386-002AB

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 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213386-001PREDNISONE10MGTABLET / ORALAB2020-06-24782e0a99824c…
2021-12-28 21:50 UTC2021-12A213386-002PREDNISONE20MGTABLET / ORALAB2020-06-24782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213386-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213386-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213386-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213386-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213386-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213386-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213386-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213386-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213386-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213386-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213386-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213386-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213386-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213386-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213386-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213386-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213386-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213386-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213386-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213386-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213386-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213386-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213386-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213386-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213386-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213386-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213386-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213386-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213386-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213386-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213386-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213386-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213386-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213386-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213386-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213386-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213386-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213386-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213386-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A213386-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE20 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 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03228706-92b9-43c9-8d73-c73aa124c58dAvailable 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
60219-1708-1prednisone100 in 1 BOTTLE, PLASTICTABLET10013
60219-1708-5prednisone500 in 1 BOTTLE, PLASTICTABLET50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1708-1EA - Each60219-1708eed53ad5-d7ba-4d21-9943-bcaf1e402a4212021-11-09
60219-1708-5EA - Each60219-17087163f63c-2e26-4419-9dc0-aeed85a54c7412021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1708PREDNISONE TABLET [AMNEAL PHARMACEUTICALS NY LLC]13Current NDC, Legacy NDC, 2 package rows20250412_03228706-92b9-43c9-8d73-c73aa124c58d.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
prednisonePREDNISONEREMEDYREPACK INC.e47a0448-331f-4846-8e63-c52c3afa274b2026-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386
prednisonePREDNISONEUnit Dose Solutions, Inc.5590d36d-dbe7-1c78-e063-6294a90ad2d42026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386
prednisonePREDNISONEAmneal Pharmaceuticals NY LLC03228706-92b9-43c9-8d73-c73aa124c58d2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386
ndc (product): 60219-1708
prednisonePREDNISONERedpharm Drug0ab0e81c-8170-6805-e063-6294a90adfc02025-12-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386
prednisonePREDNISONEA-S Medication Solutionse28359cf-0c21-487a-a1a3-d1c62cef88f92025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386
prednisonePREDNISONEA-S Medication Solutions8f9a581c-5fef-4089-aa94-7dc81ec5b5662025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386
prednisonePREDNISONEA-S Medication Solutions871540d3-39c3-460c-a855-3aeabfd872672025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386
prednisonePREDNISONEREMEDYREPACK INC.4750028a-30ad-420a-8e6b-06dc2429d4332025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386
prednisonePREDNISONEA-S Medication Solutions81cef50e-394a-49b3-8723-28df68a742d62024-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386
prednisonePREDNISONEA-S Medication Solutionsaaea2307-7893-48e9-af64-26172d08d4e82024-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386
prednisonePREDNISONENCS HealthCare of KY, LLC dba Vangard Labs7b60255f-7d0b-4f91-a75c-6682ac446f6b2024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386
prednisonePREDNISONEProficient Rx LP6a0c1192-8ce4-466d-a0f3-d878d67349cf2023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386
prednisonePREDNISONEProficient Rx LP6ec5b58c-65e9-47ee-b2ac-7d0b395a06302023-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213386
application number: ANDA213386

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN03228706-92b9-43c9-8d73-c73aa124c58d13
312615predniSONE 20 MG Oral TabletPSN03228706-92b9-43c9-8d73-c73aa124c58d13
198145prednisone 10 MG Oral TabletSCD03228706-92b9-43c9-8d73-c73aa124c58d13
312615prednisone 20 MG Oral TabletSCD03228706-92b9-43c9-8d73-c73aa124c58d13
312615predniSONE 20 MG Oral TabletPSNe28359cf-0c21-487a-a1a3-d1c62cef88f99
312615prednisone 20 MG Oral TabletSCDe28359cf-0c21-487a-a1a3-d1c62cef88f99
312615predniSONE 20 MG Oral TabletPSNe47a0448-331f-4846-8e63-c52c3afa274b8
312615predniSONE 20 MG Oral TabletPSN871540d3-39c3-460c-a855-3aeabfd872678
312615prednisone 20 MG Oral TabletSCD871540d3-39c3-460c-a855-3aeabfd872678
312615prednisone 20 MG Oral TabletSCDe47a0448-331f-4846-8e63-c52c3afa274b8
198145predniSONE 10 MG Oral TabletPSN7b60255f-7d0b-4f91-a75c-6682ac446f6b5
312615predniSONE 20 MG Oral TabletPSN7b60255f-7d0b-4f91-a75c-6682ac446f6b5
312615predniSONE 20 MG Oral TabletPSN8f9a581c-5fef-4089-aa94-7dc81ec5b5665
198145prednisone 10 MG Oral TabletSCD7b60255f-7d0b-4f91-a75c-6682ac446f6b5
312615prednisone 20 MG Oral TabletSCD7b60255f-7d0b-4f91-a75c-6682ac446f6b5
312615prednisone 20 MG Oral TabletSCD8f9a581c-5fef-4089-aa94-7dc81ec5b5665
312615predniSONE 20 MG Oral TabletPSN0ab0e81c-8170-6805-e063-6294a90adfc03
312615prednisone 20 MG Oral TabletSCD0ab0e81c-8170-6805-e063-6294a90adfc03
312615predniSONE 20 MG Oral TabletPSN2de07baf-1add-f3d1-e063-6394a90a41d82
312615predniSONE 20 MG Oral TabletPSN6a0c1192-8ce4-466d-a0f3-d878d67349cf2
312615prednisone 20 MG Oral TabletSCD2de07baf-1add-f3d1-e063-6394a90a41d82
312615prednisone 20 MG Oral TabletSCD6a0c1192-8ce4-466d-a0f3-d878d67349cf2
312615predniSONE 20 MG Oral TabletPSN26aabcb1-11db-3278-e063-6394a90a20b41
312615prednisone 20 MG Oral TabletSCD26aabcb1-11db-3278-e063-6394a90a20b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60219-1708-160219170801100 TABLET in 1 BOTTLE, PLASTIC (60219-1708-1) 100 tablet2020-06-240000-00-00NoNoCurrent
60219-1708-560219170805500 TABLET in 1 BOTTLE, PLASTIC (60219-1708-5) 500 tablet2020-06-240000-00-00NoNoCurrent