FDA.reportPublic FDA data

PREDNISOLONE ACETATE

Product NDC
70748-332
11-digit product format
707480332
Labeler code
70748
Product ID
70748-332_8b7144d6-fff1-4afd-a80b-332ff7ed80a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisolone acetate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA216935
Marketing category
ANDA
Marketing start
2024-10-11
Substance
PREDNISOLONE ACETATE
Active strength
10 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216935-001PREDNISOLONE ACETATEPREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216935-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-0279d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216935-001PREDNISOLONE ACETATE1%SUSPENSION/DROPS / OPHTHALMICAB2024-08-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216935-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216935-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216935-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216935-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216935-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216935-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216935-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216935-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216935-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216935-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216935-001AB179d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216935-001AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216935-001CGT2025-04-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A216935-001CGT2025-04-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216935-001CGT2025-04-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216935-001CGT2025-04-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216935-001CGT2025-04-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216935-001CGT2025-04-092680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216935-001CGT2025-04-09d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISOLONE ACETATE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8B2807733DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1376336Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
75fbeab1-ce8d-4999-a875-472174be5cc6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
9f10552a-9a7b-8e6c-3223-dc44310af6cfProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70748-332-02PREDNISOLONE ACETATE5 mL in 1 BOTTLESUSPENSION/ DROPS56
70748-332-02PREDNISOLONE ACETATE1 in 1 CARTONSUSPENSION/ DROPS16
70748-332-03PREDNISOLONE ACETATE1 in 1 CARTONSUSPENSION/ DROPS16
70748-332-03PREDNISOLONE ACETATE10 mL in 1 BOTTLESUSPENSION/ DROPS106
70748-332-04PREDNISOLONE ACETATE1 in 1 CARTONSUSPENSION/ DROPS16
70748-332-04PREDNISOLONE ACETATE15 mL in 1 BOTTLESUSPENSION/ DROPS156

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70748-332-02ML - Milliliter70748-332bde00392-d7d8-4fa2-9f80-d35909a040c512024-11-05
70748-332-03ML - Milliliter70748-332a01f4d27-e9ce-4292-b840-31f6caec02e212024-11-05
70748-332-04ML - Milliliter70748-3325ca4fcf5-b034-4244-9b52-fb2e85841cf612024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70748-332PREDNISOLONE ACETATE SUSPENSION/ DROPS [LUPIN PHARMACEUTICALS, INC.]5Current NDC, 6 package rows20250406_75fbeab1-ce8d-4999-a875-472174be5cc6.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
PREDNISOLONE ACETATEPREDNISOLONE ACETATEA-S Medication Solutionsf0e1b691-73ff-49ee-8a3c-71769b284ab82026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216935
application number: ANDA216935
PREDNISOLONE ACETATEPREDNISOLONE ACETATERedpharm Drug3dd0195c-8522-bbf9-e063-6394a90a9f3e2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216935
application number: ANDA216935
PREDNISOLONE ACETATEPREDNISOLONE ACETATELupin Pharmaceuticals, Inc.75fbeab1-ce8d-4999-a875-472174be5cc62025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216935
application number: ANDA216935
ndc (product): 70748-332

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN75fbeab1-ce8d-4999-a875-472174be5cc66
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD75fbeab1-ce8d-4999-a875-472174be5cc66
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY75fbeab1-ce8d-4999-a875-472174be5cc66
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSNf0e1b691-73ff-49ee-8a3c-71769b284ab83
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCDf0e1b691-73ff-49ee-8a3c-71769b284ab83
1376336prednisolone acetate 1 % Ophthalmic SuspensionSYf0e1b691-73ff-49ee-8a3c-71769b284ab83
1376336prednisoLONE acetate 1 % Ophthalmic SuspensionPSN3dd0195c-8522-bbf9-e063-6394a90a9f3e2
1376336prednisolone acetate 10 MG/ML Ophthalmic SuspensionSCD3dd0195c-8522-bbf9-e063-6394a90a9f3e2
1376336prednisolone acetate 1 % Ophthalmic SuspensionSY3dd0195c-8522-bbf9-e063-6394a90a9f3e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70748-332-02707480332021 BOTTLE in 1 CARTON (70748-332-02) / 5 mL in 1 BOTTLE1 bottle2024-10-11NoNoCurrent
70748-332-03707480332031 BOTTLE in 1 CARTON (70748-332-03) / 10 mL in 1 BOTTLE1 bottle2024-10-11NoNoCurrent
70748-332-04707480332041 BOTTLE in 1 CARTON (70748-332-04) / 15 mL in 1 BOTTLE1 bottle2024-10-11NoNoCurrent