Prednisone

Product NDC
0603-5339
11-digit product format
006035339
Labeler code
0603
Product ID
0603-5339_e6628b5c-a3e4-462b-a01a-695ed8d3ab64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA040392
Marketing category
ANDA
Marketing start
2003-02-12
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040392-001PREDNISONEPREDNISONE20MGTABLET / ORALAB2003-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040392-001AB

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 06:07:402026-07A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-123f01610625f2…
2019-09-15 20:21 UTC2019-09A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040392-001PREDNISONE20MGTABLET / ORALAB2003-02-12e64feba35796…

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 06:07:402026-07A040392-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040392-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040392-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040392-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040392-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040392-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040392-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040392-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040392-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040392-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040392-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040392-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040392-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040392-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040392-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040392-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040392-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040392-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040392-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040392-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040392-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040392-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040392-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040392-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040392-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040392-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040392-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040392-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040392-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040392-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040392-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040392-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040392-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040392-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040392-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040392-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040392-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040392-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040392-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040392-001AB1e64feba35796…

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 · 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#

NDC, Effective, Related label table
NDCEffectiveRelated label
0603-5339-212022-08-19PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-212022-08-19PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-212022-08-19PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-282022-08-19PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-282022-08-19PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-282022-08-19PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-322022-08-19PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-322022-08-19PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-322022-08-19PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-212022-07-29PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-212022-07-29PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-212022-07-29PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-282022-07-29PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-282022-07-29PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-282022-07-29PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-322022-07-29PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-322022-07-29PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5339-322022-07-29PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0603-5339-21Prednisone100 in 1 BOTTLE, PLASTICTABLET10032
0603-5339-28Prednisone500 in 1 BOTTLE, PLASTICTABLET50032
0603-5339-32Prednisone1000 in 1 BOTTLE, PLASTICTABLET100032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-5339-21EA - Each0603-5339c755f277-69c7-4676-b2fe-2bc9cac4163912012-07-24
0603-5339-28EA - Each0603-533983c832bf-3484-4d4d-9d5c-78ba2a65e8dc12012-07-24
0603-5339-32EA - Each0603-533910bb53a9-d767-485b-9ad8-1e2b44101e6d12012-07-24

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
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]3
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.]3
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [BRYANT RANCH PREPACK]2
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [H.J. HARKINS COMPANY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [REDPHARM DRUG INC.]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [REDPHARM DRUG INC.]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [REDPHARM DRUG INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [REDPHARM DRUG INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [REDPHARM DRUG INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [REDPHARM DRUG INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [REDPHARM DRUG INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-5339PREDNISONE TABLET [ENDO USA, INC.]32Current NDC, Legacy NDC, 3 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 · 3 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): 040392
application number: ANDA040392
ndc (product): 0603-5339
PrednisonePREDNISONECardinal Health 107, LLC199ed6a6-d9d9-49de-b383-5933a026591b2026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040392
application number: ANDA040392
PrednisonePREDNISONEAmerican Health Packaginga0e8d1a2-8c82-4dc0-8c2f-9da84382f34e2025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040392
application number: ANDA040392

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763185{21 (prednisone 10 MG Oral Tablet) } PackGPCKb5b088b9-8f90-468f-b7a4-a5274aa0aec932
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 TabletPSNb5b088b9-8f90-468f-b7a4-a5274aa0aec932
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 PackPSNb5b088b9-8f90-468f-b7a4-a5274aa0aec932
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 TabletPSNb5b088b9-8f90-468f-b7a4-a5274aa0aec932
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 TabletSCDb5b088b9-8f90-468f-b7a4-a5274aa0aec932
198145prednisone 10 MG Oral TabletSCD10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198146prednisone 2.5 MG Oral TabletSCD10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
312615prednisone 20 MG Oral TabletSCDb5b088b9-8f90-468f-b7a4-a5274aa0aec932
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
763185Prednisone 10 MG Oral Tablet 21 Count PackSYb5b088b9-8f90-468f-b7a4-a5274aa0aec932
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
198145predniSONE 10 MG Oral TabletPSN5e802202-77dd-4d47-abe9-3cb668fa630d21
312615predniSONE 20 MG Oral TabletPSN5e802202-77dd-4d47-abe9-3cb668fa630d21
312617predniSONE 5 MG Oral TabletPSN5e802202-77dd-4d47-abe9-3cb668fa630d21
198145prednisone 10 MG Oral TabletSCD5e802202-77dd-4d47-abe9-3cb668fa630d21
312615prednisone 20 MG Oral TabletSCD5e802202-77dd-4d47-abe9-3cb668fa630d21
312617prednisone 5 MG Oral TabletSCD5e802202-77dd-4d47-abe9-3cb668fa630d21
763183{48 (prednisone 10 MG Oral Tablet) } PackGPCKefe0c82b-9dd9-4729-b06f-06307867aca018
198145predniSONE 10 MG Oral TabletPSNefe0c82b-9dd9-4729-b06f-06307867aca018
763183predniSONE 10 MG Tablet 12 Day 48 Count PackPSNefe0c82b-9dd9-4729-b06f-06307867aca018
198146predniSONE 2.5 MG Oral TabletPSNefe0c82b-9dd9-4729-b06f-06307867aca018
312615predniSONE 20 MG Oral TabletPSNefe0c82b-9dd9-4729-b06f-06307867aca018
312617predniSONE 5 MG Oral TabletPSNefe0c82b-9dd9-4729-b06f-06307867aca018
198145prednisone 10 MG Oral TabletSCDefe0c82b-9dd9-4729-b06f-06307867aca018
198146prednisone 2.5 MG Oral TabletSCDefe0c82b-9dd9-4729-b06f-06307867aca018
312615prednisone 20 MG Oral TabletSCDefe0c82b-9dd9-4729-b06f-06307867aca018
312617prednisone 5 MG Oral TabletSCDefe0c82b-9dd9-4729-b06f-06307867aca018
763183Prednisone 10 MG Oral Tablet 48 Count PackSYefe0c82b-9dd9-4729-b06f-06307867aca018
198145predniSONE 10 MG Oral TabletPSNa0e8d1a2-8c82-4dc0-8c2f-9da84382f34e10
312615predniSONE 20 MG Oral TabletPSNa0e8d1a2-8c82-4dc0-8c2f-9da84382f34e10
312617predniSONE 5 MG Oral TabletPSNa0e8d1a2-8c82-4dc0-8c2f-9da84382f34e10
198145prednisone 10 MG Oral TabletSCDa0e8d1a2-8c82-4dc0-8c2f-9da84382f34e10
312615prednisone 20 MG Oral TabletSCDa0e8d1a2-8c82-4dc0-8c2f-9da84382f34e10
312617prednisone 5 MG Oral TabletSCDa0e8d1a2-8c82-4dc0-8c2f-9da84382f34e10
312615predniSONE 20 MG Oral TabletPSN9fcd7814-1363-4218-92c6-b0f7327958973
312615prednisone 20 MG Oral TabletSCD9fcd7814-1363-4218-92c6-b0f7327958973
198145predniSONE 10 MG Oral TabletPSN3d2eb1e3-fc2b-4820-abc6-cae1228df4c22
312615predniSONE 20 MG Oral TabletPSN3d2eb1e3-fc2b-4820-abc6-cae1228df4c22
312615predniSONE 20 MG Oral TabletPSNdfb55c19-be0d-4c9f-8169-c63749da26c22
312617predniSONE 5 MG Oral TabletPSN3d2eb1e3-fc2b-4820-abc6-cae1228df4c22
198145prednisone 10 MG Oral TabletSCD3d2eb1e3-fc2b-4820-abc6-cae1228df4c22
312615prednisone 20 MG Oral TabletSCDdfb55c19-be0d-4c9f-8169-c63749da26c22
312615prednisone 20 MG Oral TabletSCD3d2eb1e3-fc2b-4820-abc6-cae1228df4c22
312617prednisone 5 MG Oral TabletSCD3d2eb1e3-fc2b-4820-abc6-cae1228df4c22
198145predniSONE 10 MG Oral TabletPSN63e2d3c7-8120-401b-a826-c987547970261
312615predniSONE 20 MG Oral TabletPSN63e2d3c7-8120-401b-a826-c987547970261
312615predniSONE 20 MG Oral TabletPSNa651e06c-6295-4ed2-8d67-334645f05b301
312617predniSONE 5 MG Oral TabletPSN63e2d3c7-8120-401b-a826-c987547970261
198145prednisone 10 MG Oral TabletSCD63e2d3c7-8120-401b-a826-c987547970261
312615prednisone 20 MG Oral TabletSCD63e2d3c7-8120-401b-a826-c987547970261
312615prednisone 20 MG Oral TabletSCDa651e06c-6295-4ed2-8d67-334645f05b301
312617prednisone 5 MG Oral TabletSCD63e2d3c7-8120-401b-a826-c987547970261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-5339-2100603533921100 TABLET in 1 BOTTLE, PLASTIC (0603-5339-21) 100 tablet2003-02-120000-00-00NoNoCurrent
0603-5339-2800603533928500 TABLET in 1 BOTTLE, PLASTIC (0603-5339-28) 500 tablet2003-02-120000-00-00NoNoCurrent
0603-5339-32006035339321000 TABLET in 1 BOTTLE, PLASTIC (0603-5339-32) 1000 tablet2003-02-120000-00-00NoNoCurrent