FDA.reportPublic FDA data

Prednisone

Product NDC
63629-1605
11-digit product format
636291605
Labeler code
63629
Product ID
63629-1605_aeb416b3-5b23-47cc-9c0e-2aae45798f94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040256
Marketing category
ANDA
Marketing start
2002-07-12
Substance
PREDNISONE
Active strength
5 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-1605-68dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-1605-28dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-1605-08dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-1605-78dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-1605-38dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-1605-48dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-1605-88dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-1605-98dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-1605-58dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-1605-6e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-1605-2e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-1605-0e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-1605-7e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-1605-3e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-1605-4e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-1605-8e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-1605-9e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-1605-5e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-1605-69bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-1605-29bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-1605-09bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-1605-79bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-1605-39bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-1605-49bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-1605-89bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-1605-99bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-1605-59bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040256-001PREDNISONEPREDNISONE5MGTABLET / ORALAB2002-07-12
A040256-002PREDNISONEPREDNISONE10MGTABLET / ORALAB2002-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040256-001AB
A040256-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040256-001PREDNISONE5MGTABLET / ORALAB2002-07-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A040256-002PREDNISONE10MGTABLET / ORALAB2002-07-12782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040256-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040256-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040256-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040256-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040256-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040256-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040256-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040256-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040256-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040256-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040256-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040256-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040256-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040256-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040256-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040256-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040256-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040256-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040256-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040256-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040256-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040256-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040256-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040256-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040256-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040256-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040256-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040256-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040256-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040256-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040256-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040256-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040256-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040256-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040256-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040256-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040256-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040256-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040256-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040256-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE5 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
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
290a91e5-22ae-4d62-ab34-39a3117002e2Available 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
63629-1605-02022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-02022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-12022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-12022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-22022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-22022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-32022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-32022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-42022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-42022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-52022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-52022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-62022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-62022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-72022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-72022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-82022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-82022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-92022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-92022-02-15PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-02020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-02020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-12020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-12020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-22020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-22020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-32020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-32020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-42020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-42020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-52020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-52020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-62020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-62020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-72020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-72020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-82020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-82020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-92020-01-31PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
63629-1605-92020-01-31PredniSONE 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
63629-1605-0Prednisone42 in 1 BOTTLETABLET429
63629-1605-1Prednisone30 in 1 BOTTLETABLET309
63629-1605-2Prednisone78 in 1 BOTTLETABLET789
63629-1605-3Prednisone36 in 1 BOTTLETABLET369
63629-1605-4Prednisone21 in 1 BOTTLETABLET219
63629-1605-5Prednisone15 in 1 BOTTLETABLET159
63629-1605-6Prednisone100 in 1 BOTTLETABLET1009
63629-1605-7Prednisone20 in 1 BOTTLETABLET209
63629-1605-8Prednisone10 in 1 BOTTLETABLET109
63629-1605-9Prednisone90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1605-0EA - Each63629-16053473df04-1e9e-4b27-ac9d-30719d1205b912015-02-02
63629-1605-1EA - Each63629-1605023c150e-a42b-44bc-9551-c5f76c65cd5012012-07-24
63629-1605-2EA - Each63629-16053d748d1b-8fad-4916-8165-1171455061d712012-07-24
63629-1605-3EA - Each63629-16059179d126-7d0e-4a7e-a095-b06f54b21d2312012-07-24
63629-1605-4EA - Each63629-1605ffc98649-056d-4516-ae0e-e710b4a667dd12012-07-24
63629-1605-5EA - Each63629-16058cecedfb-b099-4b73-8428-15a34701d14b12012-07-24
63629-1605-6EA - Each63629-1605fdcc48ec-b4bf-49c0-b159-73593b49512312012-07-24
63629-1605-7EA - Each63629-1605da1ba240-b13b-43e7-aea6-fc9cfd426aaf12012-07-24
63629-1605-8EA - Each63629-1605e9beccef-cde7-4d3c-bba1-fb30413a6b9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [BRYANT RANCH PREPACK]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1605PREDNISONE TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 10 package rows20241017_290a91e5-22ae-4d62-ab34-39a3117002e2.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEBryant Ranch Prepack931171e2-0bdb-451e-b737-72ce3ffbed532026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEBryant Ranch Prepack55aedced-d945-4bd2-9aa8-0f18b89a0e7f2026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEBryant Ranch Prepackdc3bbb97-6588-46f4-b0ad-47596874ad0c2026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEBryant Ranch Prepack290a91e5-22ae-4d62-ab34-39a3117002e22026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
ndc (product): 63629-1605
PrednisonePREDNISONEREMEDYREPACK INC.746b0bcd-122e-4ea8-a824-28415073a38e2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEMajor Pharmaceuticals57b98930-92ab-4b77-a033-ae9895ee718a2026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEPar Health USA, LLC10fe5a3b-84dc-4600-87c2-b80c97ce18cf2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutionsb5b088b9-8f90-468f-b7a4-a5274aa0aec92026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutions71295010-5adb-499b-a03a-5c78b5e79b2d2026-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONECardinal Health 107, LLC199ed6a6-d9d9-49de-b383-5933a026591b2026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutionsefe0c82b-9dd9-4729-b06f-06307867aca02026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEAmerican Health Packaginga0e8d1a2-8c82-4dc0-8c2f-9da84382f34e2025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONECardinal Health 107, LLC568b8880-7997-4786-8c57-28816ce526552025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEPreferred Pharmaceuticals, Inc.f89bd1dc-88cd-4aef-a7ae-6310f38a34232025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutions95cf05e5-1446-43f5-8447-c04877a747812024-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutions410988ea-456a-454e-932c-fcbdbef04ba92024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEA-S Medication Solutions44069d49-4cf4-4f1e-9fbd-b496c6ca81a12024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEProficient Rx LP7d52bf53-76e3-4826-a12b-b16a8560bafc2021-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256
PrednisonePREDNISONEAphena Pharma Solutions - Tennessee, LLCb902ed21-c776-4046-8fbc-9ce95b16b1392017-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040256
application number: ANDA040256

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSN290a91e5-22ae-4d62-ab34-39a3117002e29
312617prednisone 5 MG Oral TabletSCD290a91e5-22ae-4d62-ab34-39a3117002e29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1605-06362916050042 TABLET in 1 BOTTLE (63629-1605-0) 42 tablet2010-06-080000-00-00NoNoCurrent
63629-1605-16362916050130 TABLET in 1 BOTTLE (63629-1605-1) 30 tablet2004-12-070000-00-00NoNoCurrent
63629-1605-26362916050278 TABLET in 1 BOTTLE (63629-1605-2) 78 tablet2005-03-180000-00-00NoNoCurrent
63629-1605-36362916050336 TABLET in 1 BOTTLE (63629-1605-3) 36 tablet2010-03-120000-00-00NoNoCurrent
63629-1605-46362916050421 TABLET in 1 BOTTLE (63629-1605-4) 21 tablet2005-01-100000-00-00NoNoCurrent
63629-1605-56362916050515 TABLET in 1 BOTTLE (63629-1605-5) 15 tablet2005-02-110000-00-00NoNoCurrent
63629-1605-663629160506100 TABLET in 1 BOTTLE (63629-1605-6) 100 tablet2008-09-150000-00-00NoNoCurrent
63629-1605-76362916050720 TABLET in 1 BOTTLE (63629-1605-7) 20 tablet2009-06-150000-00-00NoNoCurrent
63629-1605-86362916050810 TABLET in 1 BOTTLE (63629-1605-8) 10 tablet2010-01-180000-00-00NoNoCurrent
63629-1605-96362916050990 TABLET in 1 BOTTLE (63629-1605-9) 90 tablet2010-04-200000-00-00NoNoCurrent