Prednisone

Product NDC
66267-172
11-digit product format
662670172
Labeler code
66267
Product ID
66267-172_10f56bf8-3a4b-81e4-e063-6294a90aef03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040362
Marketing category
ANDA
Marketing start
2001-08-29
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

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

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
A040362-001PREDNISONEPREDNISONE10MGTABLET / ORALAB2001-08-29
A040362-002PREDNISONEPREDNISONE5MGTABLET / ORALAB2001-08-29
A040362-003PREDNISONEPREDNISONE20MGTABLET / ORALAB2005-06-29
A040362-004PREDNISONEPREDNISONE2.5MGTABLET / ORALAB2023-04-17
A040362-005PREDNISONEPREDNISONE50MGTABLET / ORALAB2023-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A040362-001AB
A040362-002AB
A040362-003AB
A040362-004AB
A040362-005AB

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 · 167 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-001PREDNISONE10MGTABLET / ORALAB2001-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-002PREDNISONE5MGTABLET / ORALAB2001-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-003PREDNISONE20MGTABLET / ORALAB2005-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-004PREDNISONE2.5MGTABLET / ORALAB2023-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-005PREDNISONE50MGTABLET / ORALAB2023-04-175bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 167 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040362-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040362-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040362-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040362-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040362-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040362-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040362-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040362-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040362-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040362-005AB15bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
Prednisone
Listing expiration
2026-12-31

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
63102d75-9b2b-84a9-e053-2a91aa0a317dAvailable 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
66267-172-06Prednisone6 in 1 BOTTLETABLET69
66267-172-08Prednisone8 in 1 BOTTLETABLET89
66267-172-10Prednisone10 in 1 BOTTLETABLET109
66267-172-14Prednisone14 in 1 BOTTLETABLET149
66267-172-15Prednisone15 in 1 BOTTLETABLET159
66267-172-20Prednisone20 in 1 BOTTLETABLET209
66267-172-21Prednisone21 in 1 BOTTLETABLET219
66267-172-30Prednisone30 in 1 BOTTLETABLET309
66267-172-40Prednisone40 in 1 BOTTLETABLET409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-172-10EA - Each66267-172b22d33c0-9323-4e40-bba0-7be5faa4885a12018-02-20
66267-172-15EA - Each66267-17291deb63b-d0ff-4f88-8986-d1f16461ffac12018-02-20
66267-172-20EA - Each66267-172915efc0f-26c3-4b0d-b73a-4aa112b578e212018-02-20
66267-172-30EA - Each66267-17206366a8f-00d1-4a02-9099-b389888f622412018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-172PREDNISONE TABLET [NUCARE PHARMACEUTICALS,INC.]9Current NDC, Legacy NDC, 9 package rows20240210_63102d75-9b2b-84a9-e053-2a91aa0a317d.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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEA-S Medication Solutions74102cc5-7a1a-4a0f-a07f-a4b0f86bcabf2025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEA-S Medication Solutionsdc94273f-af06-4bd5-9ce3-ce0a0f36587b2025-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAdvanced Rx of Tennessee, LLCaf863b9e-964b-3b1e-e053-2995a90ab93a2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAdvanced Rx Pharmacy of Tennessee, LLCb3dbf833-b929-8c85-e053-2995a90a58962024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAdvanced Rx Pharmacy of Tennessee, LLCe1e7d14b-80b2-f57e-e053-2995a90af1122024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAdvanced Rx Pharmacy of Tennessee, LLCb3dbff9f-610f-7782-e053-2a95a90a71c12024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.62fdf3c2-cfa9-d573-e053-2a91aa0a833b2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.62ec965c-e682-9920-e053-2a91aa0adcdb2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.62ff1da3-79aa-676a-e053-2991aa0a4a9f2024-07-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEA-S Medication Solutions751b7f62-f92b-4b7c-a588-2c882d5d1ce32024-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEA-S Medication Solutionscb1b0dc0-6916-4e6f-9775-26ea0f593f832024-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.63106192-35d5-6989-e053-2991aa0aa7142024-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEA-S Medication Solutions5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d22024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.63102d75-9b2b-84a9-e053-2a91aa0a317d2024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
ndc (product): 66267-172
PrednisonePREDNISONEProficient Rx LP5961b1d4-6a4c-452f-b3f1-c99f3a9a64452023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEAsclemed USA, Inc.dc663fd3-b149-48ae-a3f3-6abaa4808cc62020-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEProficient Rx LPe4555299-af68-416f-8999-9bb703a45e772019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362
PrednisonePREDNISONEProficient Rx LP7c650dc8-43f6-4257-81ed-c93b00202d062019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040362
application number: ANDA040362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-172-06662670172066 TABLET in 1 BOTTLE (66267-172-06) 6 tablet2018-01-18NoNoCurrent
66267-172-08662670172088 TABLET in 1 BOTTLE (66267-172-08) 8 tablet2018-01-18NoNoCurrent
66267-172-106626701721010 TABLET in 1 BOTTLE (66267-172-10) 10 tablet2018-01-180000-00-00NoNoCurrent
66267-172-146626701721414 TABLET in 1 BOTTLE (66267-172-14) 14 tablet2018-01-18NoNoCurrent
66267-172-156626701721515 TABLET in 1 BOTTLE (66267-172-15) 15 tablet2018-01-180000-00-00NoNoCurrent
66267-172-206626701722020 TABLET in 1 BOTTLE (66267-172-20) 20 tablet2018-01-180000-00-00NoNoCurrent
66267-172-216626701722121 TABLET in 1 BOTTLE (66267-172-21) 21 tablet2018-01-180000-00-00NoNoCurrent
66267-172-306626701723030 TABLET in 1 BOTTLE (66267-172-30) 30 tablet2018-01-180000-00-00NoNoCurrent
66267-172-406626701724040 TABLET in 1 BOTTLE (66267-172-40) 40 tablet2018-01-180000-00-00NoNoCurrent