Home NDC 0054-3721 PredniSONE Intensol
Product NDC 0054-3721
11-digit product format 000543721
Labeler code 0054
Product ID 0054-3721_523ad364-8d95-4679-9290-446d61f36eb5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PredniSONE Intensol
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA088810
Marketing category ANDA
Marketing start 1985-02-20
Substance PREDNISONE
Active strength 5 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 42 .
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 A088810-001 PREDNISONE INTENSOL PREDNISONE 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20
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 · 42 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 2026-08-18 06:07:40 2026-07 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RLD, RS 1985-02-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088810-001 PREDNISONE INTENSOL 5MG/ML SOLUTION / ORAL RS 1985-02-20 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base PredniSONE Intensol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISONE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VB0R961HZT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198144 Internal RxNorm lookup 198145 Internal RxNorm lookup 198146 Internal RxNorm lookup 198148 Internal RxNorm lookup 205301 Internal RxNorm lookup 312615 Internal RxNorm lookup 312617 Internal RxNorm lookup 315187 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-3721-44 PredniSONE Intensol 30 mL in 1 BOTTLE, GLASS SOLUTION, CONCENTRATE 30 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PREDNISONE ACTIVE INGREDIENT VB0R961HZT PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 PREDNISONE ACTIVE MOIETY VB0R961HZT PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 FRUCTOSE INACTIVE INGREDIENT 6YSS42VSEV PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 LACTOSE INACTIVE INGREDIENT J2B2A4N98G PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 MALTOL INACTIVE INGREDIENT 3A9RD92BS4 PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 PEPPERMINT OIL INACTIVE INGREDIENT AV092KU4JH PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 SODIUM GLYCOLATE INACTIVE INGREDIENT B75E535IMI PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7 WATER INACTIVE INGREDIENT 059QF0KO0R PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-3721 PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.] 23 Current NDC, Legacy NDC, 1 package rows 20240308_3115aef0-fd50-4ec8-a064-3effb695f3f2.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-3721-44 00054372144 30 mL in 1 BOTTLE, GLASS (0054-3721-44) 30 ml 1985-02-20 0000-00-00 No No Current