Home NDC 72603-399-01 Methylphenidate Hydrochloride
Product NDC 72603-399
Requested package NDC 72603-399-01
11-digit product format 726030399
Labeler code 72603
Product ID 72603-399_24936e25-28cd-53ce-e063-6294a90ad99d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate Hydrochloride
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Northstar Rx LLC
Application ANDA217229
Marketing category ANDA
Marketing start 2025-02-01
Substance METHYLPHENIDATE HYDROCHLORIDE
Active strength 72 mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule CII
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217229-001 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217229-001 AB
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 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 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217229-001 METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL AB 2023-08-25 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Methylphenidate Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPHENIDATE HYDROCHLORIDE 72 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4B3SC438HI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1995461 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 72603-399-01 Methylphenidate Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, EXTENDED RELEASE 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72603-399 METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC] 1 Current NDC, 1 package rows 20250201_768bf181-d0d8-49e5-9c87-cacbb069e0b2.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72603-399-01 72603039901 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72603-399-01) 2025-02-01 No No Current