Deltasone 20mg prednisone tablets

Manufacturer
Oculus Innovative Sciences
Effective date
2017-11-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:24:44

Label at a glance#

ProductDeltasone
Active ingredientPREDNISONE
Label structure2 sections

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

Warnings: Keep this product out of reach
of children. In case of accidental overdose,
call a doctor or poison control center
immediately.
All prescriptions using this product shall be
pursuant to state statutes as applicable.
This product may be administered only
under a physician’s supervision.
Call your doctor about side effects.
You may report side effects to FDA at
1-800-FDA-1088.

Deltasone 20mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Detasone 20mgDetasone 20mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
206997Deltasone 20 MG Oral TabletPSN2
312615predniSONE 20 MG Oral TabletPSN2
206997prednisone 20 MG Oral Tablet [Deltasone]SBD2
312615prednisone 20 MG Oral TabletSCD2
206997Deltasone 20 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PREDNISONE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20190419

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69668-120-202020-01-31C16284748780-19d75b9d0-c676-f424-e053-dadaa90a57ceDeltasone 20mg prednisone tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69668-120-20Deltasone20 mg in 1 BOTTLETABLET202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69668-120DELTASONE (PREDNISONE) TABLET [OCULUS INNOVATIVE SCIENCES]2Legacy NDC, 1 package rows20171107_18bebd56-4848-32ae-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69668-120-20EA - Each69668-1200e259432-010e-4a44-b86a-3858b7d6387512015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZT1
PREDNISONEACTIVE MOIETYVB0R961HZT1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69668-12069668-120-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
PREDNISONEVB0R961HZTACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A083677-001PREDNISONEPREDNISONE20MGTABLET / ORALABApproved before 1982
A083677-002PREDNISONEPREDNISONE5MGTABLET / ORALABApproved before 1982
A083677-003PREDNISONEPREDNISONE10MGTABLET / ORALAB1985-12-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A083677-001AB
A083677-002AB
A083677-003AB

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 · 53 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A083677-001PREDNISONE20MGTABLET / ORALABApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08A083677-002PREDNISONE5MGTABLET / ORALABApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08A083677-003PREDNISONE10MGTABLET / ORALAB1985-12-0484e616aacf4f…
2026-08-18 06:07:402026-07A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A083677-002PREDNISONE5MGTABLET / ORALABApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A083677-003PREDNISONE10MGTABLET / ORALAB1985-12-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083677-002PREDNISONE5MGTABLET / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083677-003PREDNISONE10MGTABLET / ORALAB1985-12-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083677-001PREDNISONE20MGTABLET / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083677-002PREDNISONE5MGTABLET / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083677-003PREDNISONE10MGTABLET / ORALAB1985-12-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083677-001PREDNISONE20MGTABLET / ORALABApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083677-001PREDNISONE20MGTABLET / ORALABApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A083677-001PREDNISONE20MGTABLET / ORALABApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083677-001PREDNISONE20MGTABLET / ORALABApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A083677-001PREDNISONE20MGTABLET / ORALABApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A083677-001PREDNISONE20MGTABLET / ORALABApproved before 1982ea1830bbd6c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A083677-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A083677-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A083677-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A083677-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A083677-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A083677-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A083677-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083677-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083677-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083677-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083677-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083677-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A083677-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083677-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083677-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083677-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083677-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083677-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083677-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A083677-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083677-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083677-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083677-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A083677-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083677-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A083677-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A083677-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A083677-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A083677-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A083677-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083677-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A083677-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A083677-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A083677-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A083677-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A083677-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A083677-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A083677-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A083677-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A083677-001AB1ea1830bbd6c7…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5d69215d-3754-782f-e053-2a91aa0a2d8218bebd56-4848-32ae-e054-00144ff88e882017-11-07WarningsExact identifier
spl id: 5d69215d-3754-782f-e053-2a91aa0a2d82
spl set id: 18bebd56-4848-32ae-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.