Prednisone

Product NDC
0603-5335
11-digit product format
006035335
Labeler code
0603
Product ID
0603-5335_e6628b5c-a3e4-462b-a01a-695ed8d3ab64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA040584
Marketing category
ANDA
Marketing start
2004-12-21
Substance
PREDNISONE
Active strength
1 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040584-001PREDNISONEPREDNISONE1MGTABLET / ORALAB2004-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040584-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040584-001PREDNISONE1MGTABLET / ORALAB2004-12-21e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040584-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040584-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040584-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040584-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040584-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040584-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040584-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040584-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040584-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040584-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040584-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040584-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040584-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040584-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040584-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040584-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040584-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040584-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040584-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040584-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040584-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040584-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040584-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040584-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040584-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040584-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040584-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040584-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040584-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040584-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040584-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040584-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040584-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040584-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040584-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040584-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040584-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040584-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040584-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040584-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE1 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 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198144Internal RxNorm lookup
198145Internal RxNorm lookup
198146Internal RxNorm lookup
312615Internal RxNorm lookup
312617Internal RxNorm lookup
763179Internal RxNorm lookup
763181Internal RxNorm lookup
763183Internal RxNorm lookup
763185Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
10fe5a3b-84dc-4600-87c2-b80c97ce18cfAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0603-5335-21Prednisone100 in 1 BOTTLE, PLASTICTABLET10032
0603-5335-32Prednisone1000 in 1 BOTTLE, PLASTICTABLET100032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-5335-21EA - Each0603-5335e6da4f44-eb34-4cb5-b138-e3a528e8df9412012-07-24
0603-5335-32EA - Each0603-5335ff9c3cfc-4580-4feb-b8f2-bd94abdb53fe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
SILICON DIOXIDE, COLLOIDALINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-5335PREDNISONE TABLET [ENDO USA, INC.]32Current NDC, Legacy NDC, 2 package rows20240927_10fe5a3b-84dc-4600-87c2-b80c97ce18cf.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEPar Health USA, LLC10fe5a3b-84dc-4600-87c2-b80c97ce18cf2026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040584
application number: ANDA040584
ndc (product): 0603-5335
PrednisonePREDNISONEBryant Ranch Prepack0062fcc7-aa08-4990-9d33-d798725907f12026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040584
application number: ANDA040584
PrednisonePREDNISONEBryant Ranch Prepacke4c1c8c5-0aa1-4531-aa7a-8567ac8dcba82026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040584
application number: ANDA040584
PREDNISONEPREDNISONEDIRECT RX2a053775-6f6a-455e-b9a8-8b60e6062db32026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040584
application number: ANDA040584
PrednisonePREDNISONEBryant Ranch Prepack0b2c2085-c4da-4441-ae5e-eefe26fd199e2025-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040584
application number: ANDA040584

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198144predniSONE 1 MG Oral TabletPSN0b2c2085-c4da-4441-ae5e-eefe26fd199e107
198144prednisone 1 MG Oral TabletSCD0b2c2085-c4da-4441-ae5e-eefe26fd199e107
198144predniSONE 1 MG Oral TabletPSN0062fcc7-aa08-4990-9d33-d798725907f1104
198144prednisone 1 MG Oral TabletSCD0062fcc7-aa08-4990-9d33-d798725907f1104
763185{21 (prednisone 10 MG Oral Tablet) } PackGPCK10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763181{21 (prednisone 5 MG Oral Tablet) } PackGPCK10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763183{48 (prednisone 10 MG Oral Tablet) } PackGPCK10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763179{48 (prednisone 5 MG Oral Tablet) } PackGPCK10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198144predniSONE 1 MG Oral TabletPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198145predniSONE 10 MG Oral TabletPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763183predniSONE 10 MG Tablet 12 Day 48 Count PackPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763185predniSONE 10 MG Tablet 6 Day 21 Count PackPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198146predniSONE 2.5 MG Oral TabletPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
312615predniSONE 20 MG Oral TabletPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
312617predniSONE 5 MG Oral TabletPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763179predniSONE 5 MG Tablet 12 Day 48 Count PackPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763181predniSONE 5 MG Tablet 21 Count PackPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198144prednisone 1 MG Oral TabletSCD10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198145prednisone 10 MG Oral TabletSCD10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198146prednisone 2.5 MG Oral TabletSCD10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
312615prednisone 20 MG Oral TabletSCD10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
312617prednisone 5 MG Oral TabletSCD10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763185Prednisone 10 MG Oral Tablet 21 Count PackSY10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763183Prednisone 10 MG Oral Tablet 48 Count PackSY10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763181Prednisone 5 MG Oral Tablet 21 Count PackSY10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763179Prednisone 5 MG Oral Tablet 48 Count PackSY10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198144predniSONE 1 MG Oral TabletPSNe4c1c8c5-0aa1-4531-aa7a-8567ac8dcba81
198144prednisone 1 MG Oral TabletSCDe4c1c8c5-0aa1-4531-aa7a-8567ac8dcba81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-5335-2100603533521100 TABLET in 1 BOTTLE, PLASTIC (0603-5335-21) 100 tablet2004-12-210000-00-00NoNoCurrent
0603-5335-32006035335321000 TABLET in 1 BOTTLE, PLASTIC (0603-5335-32) 1000 tablet2004-12-210000-00-00NoNoCurrent