Home NDC 51672-1338-5 Flo-Pred
Product NDC 51672-1338
Requested package NDC 51672-1338-5
11-digit product format 516721338
Labeler code 51672
Product ID 51672-1338_79fbfd7c-6b29-466c-8e65-015be1652aea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisolone Acetate
Dosage form SUSPENSION
Route ORAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application NDA022067
Marketing category NDA
Marketing start 2008-01-17
Marketing end 0000-00-00
Substance PREDNISOLONE ACETATE
Active strength 17 mg/5mL
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022067-001 FLO-PRED PREDNISOLONE ACETATE EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 N022067-002 FLO-PRED PREDNISOLONE ACETATE EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022067-001 7799331 2028-10-11 U-1068 Drug product 2012-04-16 N022067-001 7799331 2028-10-11 U-139 Drug product 2012-04-16 N022067-002 7799331 2028-10-11 U-1068 Drug product N022067-002 7799331 2028-10-11 U-139 Drug product
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022067-001 FLO-PRED EQ 5MG BASE/5ML SUSPENSION / ORAL 2008-01-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022067-002 FLO-PRED EQ 15MG BASE/5ML SUSPENSION / ORAL 2008-01-17 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022067-001 7799331 2028-10-11 U-1068 Drug product 2012-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022067-001 7799331 2028-10-11 U-139 Drug product 2012-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022067-002 7799331 2028-10-11 U-139 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022067-002 7799331 2028-10-11 U-1068 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022067-001 7799331 2028-10-11 U-1068 Drug product 2012-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022067-001 7799331 2028-10-11 U-139 Drug product 2012-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022067-002 7799331 2028-10-11 U-139 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022067-002 7799331 2028-10-11 U-1068 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022067-001 7799331 2028-10-11 U-1068 Drug product 2012-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022067-001 7799331 2028-10-11 U-139 Drug product 2012-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022067-002 7799331 2028-10-11 U-139 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022067-002 7799331 2028-10-11 U-1068 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022067-001 7799331 2028-10-11 U-1068 Drug product 2012-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022067-001 7799331 2028-10-11 U-139 Drug product 2012-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022067-002 7799331 2028-10-11 U-139 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022067-002 7799331 2028-10-11 U-1068 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022067-001 7799331 2028-10-11 U-1068 Drug product 2012-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022067-001 7799331 2028-10-11 U-139 Drug product 2012-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022067-002 7799331 2028-10-11 U-139 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022067-002 7799331 2028-10-11 U-1068 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022067-001 7799331 2028-10-11 U-1068 Drug product 2012-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022067-001 7799331 2028-10-11 U-139 Drug product 2012-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022067-002 7799331 2028-10-11 U-139 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022067-002 7799331 2028-10-11 U-1068 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022067-001 7799331 2028-10-11 U-1068 Drug product 2012-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022067-001 7799331 2028-10-11 U-139 Drug product 2012-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022067-002 7799331 2028-10-11 U-139 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022067-002 7799331 2028-10-11 U-1068 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022067-001 7799331 2028-10-11 U-1068 Drug product 2012-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022067-001 7799331 2028-10-11 U-139 Drug product 2012-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022067-002 7799331 2028-10-11 U-139 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022067-002 7799331 2028-10-11 U-1068 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022067-001 7799331 2028-10-11 U-1068 Drug product 2012-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022067-001 7799331 2028-10-11 U-139 Drug product 2012-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022067-002 7799331 2028-10-11 U-139 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022067-002 7799331 2028-10-11 U-1068 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022067-001 7799331 2028-10-11 U-1068 Drug product 2012-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022067-001 7799331 2028-10-11 U-139 Drug product 2012-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022067-002 7799331 2028-10-11 U-139 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022067-002 7799331 2028-10-11 U-1068 Drug product d06236e962d9…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Prednisolone Acetate ACTIVE INGREDIENT 8B2807733D FLO-PRED (PREDNISOLONE ACETATE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 prednisolone ACTIVE MOIETY 9PHQ9Y1OLM FLO-PRED (PREDNISOLONE ACETATE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 Butylparaben INACTIVE INGREDIENT 3QPI1U3FV8 FLO-PRED (PREDNISOLONE ACETATE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 Carbomer Homopolymer Type B INACTIVE INGREDIENT HHT01ZNK31 FLO-PRED (PREDNISOLONE ACETATE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K FLO-PRED (PREDNISOLONE ACETATE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 Glycerin INACTIVE INGREDIENT PDC6A3C0OX FLO-PRED (PREDNISOLONE ACETATE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 Poloxamer 188 INACTIVE INGREDIENT LQA7B6G8JG FLO-PRED (PREDNISOLONE ACETATE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 FLO-PRED (PREDNISOLONE ACETATE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I FLO-PRED (PREDNISOLONE ACETATE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 FLO-PRED (PREDNISOLONE ACETATE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6 water INACTIVE INGREDIENT 059QF0KO0R FLO-PRED (PREDNISOLONE ACETATE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-1338-5 51672133805 1 BOTTLE in 1 CARTON (51672-1338-5) > 37 mL in 1 BOTTLE 1 bottle 2008-01-17 0000-00-00 No No Current