Home NDC 17856-3722-1 PredniSONE
Product NDC 17856-3722
Requested package NDC 17856-3722-1
11-digit product format 178563722
Labeler code 17856
Product ID 17856-3722_5baf5a69-3431-f2ff-e063-6394a90af439
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PredniSONE
Dosage form SOLUTION
Route ORAL
Labeler Atlantic Biologicals Corps
Application ANDA088703
Marketing category ANDA
Marketing start 1986-12-13
Substance PREDNISONE
Active strength 5 mg/5mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A088703-001 PREDNISONE PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08
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 · 43 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 2026-09-14 22:38:34 2026-08 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RS 1984-11-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RS 1984-11-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RS 1984-11-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RS 1984-11-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RS 1984-11-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RS 1984-11-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RS 1984-11-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RS 1984-11-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RS 1984-11-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RS 1984-11-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RS 1984-11-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RS 1984-11-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088703-001 PREDNISONE 5MG/5ML SOLUTION / ORAL RLD, RS 1984-11-08 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PredniSONE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISONE 5 mg/5mL
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2025-04-18 PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL 2025-04-18 PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL 2025-04-18 PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL 2025-04-18 PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL 2020-01-31 PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL 2020-01-31 PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL 2020-01-31 PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL 2020-01-31 PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-3722-1 PredniSONE 5 mL in 1 CUP SOLUTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-3722 PREDNISONE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 5 Current NDC, Legacy NDC, 1 package rows 20250525_07be390e-ef1e-4bf9-a9da-4338b5f6cfa5.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PredniSONE PREDNISONE Hikma Pharmaceuticals USA Inc. 3115aef0-fd50-4ec8-a064-3effb695f3f2 2025-04-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 088703 application number: ANDA088703
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 17856-3722-1 17856372201 5 mL in 1 CUP (17856-3722-1) 5 ml 2016-05-05 No No Current