prednisone

Product NDC
64380-835
11-digit product format
643800835
Labeler code
64380
Product ID
64380-835_c389b525-c68a-43dc-bacc-c75707b391b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA208412
Marketing category
ANDA
Marketing start
2021-09-01
Substance
PREDNISONE
Active strength
2.5 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208412-001PREDNISONEPREDNISONE10MGTABLET / ORALAB2021-02-11
A208412-002PREDNISONEPREDNISONE20MGTABLET / ORALAB2021-02-11
A208412-003PREDNISONEPREDNISONE50MGTABLET / ORALAB2022-01-11
A208412-004PREDNISONEPREDNISONE2.5MGTABLET / ORALAB2020-11-20
A208412-005PREDNISONEPREDNISONE5MGTABLET / ORALAB2020-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208412-001AB
A208412-002AB
A208412-003AB
A208412-004AB
A208412-005AB

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 4 · 131 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-001PREDNISONE10MGTABLET / ORALAB2021-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-002PREDNISONE20MGTABLET / ORALAB2021-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-003PREDNISONE50MGTABLET / ORALAB2022-01-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-004PREDNISONE2.5MGTABLET / ORALAB2020-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-005PREDNISONE5MGTABLET / ORALAB2020-11-202680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 131 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208412-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208412-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208412-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208412-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208412-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208412-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208412-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208412-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208412-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208412-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208412-005AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE2.5 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
198146Internal RxNorm lookup
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
52010a34-aadb-4561-ac4a-3ee53f5e3566Available 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
64380-835-01prednisone10 in 1 BLISTER PACKTABLET1010
64380-835-01prednisone10 in 1 CARTONTABLET1010
64380-835-06prednisone100 in 1 BOTTLE, PLASTICTABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-835-06EA - Each64380-8354789d21c-d6b0-4240-a9f3-fd0892245afc12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-835PREDNISONE TABLET [STRIDES PHARMA SCIENCE LIMITED]9Current NDC, Legacy NDC, 3 package rows20250116_52010a34-aadb-4561-ac4a-3ee53f5e3566.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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
prednisonePREDNISONEREMEDYREPACK INC.23b12d22-97d6-426e-bf9c-dd6c2ff773702026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEPreferred Pharmaceuticals Inc.1e74ac55-4a48-4bf5-bfed-36c0fa37dd9f2026-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEPreferred Pharmaceuticals Inc.ce7663a7-4c91-4790-aa43-96f259b3bb182026-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.af5d0f73-2aef-4db1-ae25-6d465c9f0ca12026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.5218e88b-468b-4d60-ab7e-78cca632b23a2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
PrednisonePREDNISONECardinal Health 107, LLCcdc2b903-5d86-45c1-b97c-2da48445dbdd2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONESt. Mary's Medical Park Pharmacye4437eec-eadf-7c8b-e053-2a95a90af8462026-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONECoupler LLC53864d75-06ca-5c2a-e063-6394a90ad9662026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEBryant Ranch Prepackecc48869-3812-4440-a398-749b280620592026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEAmerican Health Packagingfdcd49a6-6cb1-49f8-9f4c-feb475c129b32026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONECardinal Health 107, LLC1d797f3e-a46c-42bc-91bb-c570ae8ca8c22026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.ea4070e1-080d-4feb-9561-3910c6b712dd2026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.b3b70d6f-dc44-4a54-b39b-2762f37d55752026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEQPharma Inc11870c93-fe64-e6c9-e063-6394a90a53342026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEQPharma Incf795ea1d-f41a-6100-e053-6394a90a63a42026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
PrednisonePREDNISONEDirect_Rxf6051257-2144-4487-e053-2995a90a973b2026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEBryant Ranch Prepackfbfd4e2b-3c8f-43c8-bcbe-da1ac4be75c52026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEProficient Rx LP4b37ada5-1f22-46d5-a794-fd1477c0eb9b2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONESportpharm LLC5dde7256-d3b8-400d-a0eb-c60078bfc5d92026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412
prednisonePREDNISONEREMEDYREPACK INC.e9a74862-6a3b-4247-837a-389761b5c3522026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208412
application number: ANDA208412

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198146predniSONE 2.5 MG Oral TabletPSN07d5e455-ac3b-4890-9619-609dd0be9106104
198146prednisone 2.5 MG Oral TabletSCD07d5e455-ac3b-4890-9619-609dd0be9106104
198146predniSONE 2.5 MG Oral TabletPSN52010a34-aadb-4561-ac4a-3ee53f5e356610
312617predniSONE 5 MG Oral TabletPSN52010a34-aadb-4561-ac4a-3ee53f5e356610
198146prednisone 2.5 MG Oral TabletSCD52010a34-aadb-4561-ac4a-3ee53f5e356610
312617prednisone 5 MG Oral TabletSCD52010a34-aadb-4561-ac4a-3ee53f5e356610
198146predniSONE 2.5 MG Oral TabletPSNd40a97f6-60d1-4dbc-b4dc-650d82af5fae7
198146prednisone 2.5 MG Oral TabletSCDd40a97f6-60d1-4dbc-b4dc-650d82af5fae7
198146predniSONE 2.5 MG Oral TabletPSN930b5eea-3ec8-47df-a76d-1e0bc0b5c5b24
198146prednisone 2.5 MG Oral TabletSCD930b5eea-3ec8-47df-a76d-1e0bc0b5c5b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-835-016438008350110 BLISTER PACK in 1 CARTON (64380-835-01) / 10 TABLET in 1 BLISTER PACK10 blister pack2021-09-010000-00-00NoNoCurrent
64380-835-0664380083506100 TABLET in 1 BOTTLE, PLASTIC (64380-835-06) 100 tablet2021-09-010000-00-00NoNoCurrent