Home NDC 62135-330-41 Prednisolone Sodium Phosphate
Product NDC 62135-330
Requested package NDC 62135-330-41
11-digit product format 621350330
Labeler code 62135
Product ID 62135-330_4abaeb5a-975a-41b9-e063-6294a90ac367
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name prednisolone sodium phosphate
Dosage form SOLUTION
Route ORAL
Labeler Chartwell RX, LLC.
Application ANDA075988
Marketing category ANDA
Marketing start 2004-05-25
Substance PREDNISOLONE SODIUM PHOSPHATE
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075988-001 PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075988-001 AA
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 · 41 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 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075988-001 PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2004-05-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Prednisolone Sodium Phosphate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISOLONE SODIUM PHOSPHATE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IV021NXA9J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312614 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-330-05 Prednisolone Sodium Phosphate 5 mL in 1 CUP SOLUTION 5 11 62135-330-24 Prednisolone Sodium Phosphate 2 in 1 BOX SOLUTION 2 11 62135-330-24 Prednisolone Sodium Phosphate 10 in 1 TRAY SOLUTION 10 11 62135-330-41 Prednisolone Sodium Phosphate 120 mL in 1 BOTTLE SOLUTION 120 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-330 PREDNISOLONE SODIUM PHOSPHATE SOLUTION [CHARTWELL RX, LLC.] 10 Current NDC, Legacy NDC, 4 package rows 20241018_2d8c861d-3756-4b75-aaa9-1b82cf11eb94.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 · 2 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 62135-330-41 62135033041 120 mL in 1 BOTTLE (62135-330-41) 120 ml 2021-05-08 0000-00-00 No No Current