Home NDC 72162-2040-5 Methylphenidate Hydrochloride
Product NDC 72162-2040
Requested package NDC 72162-2040-5
11-digit product format 721622040
Labeler code 72162
Product ID 72162-2040_d2d71458-ab2e-4d49-b988-481f0764f9df
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA091601
Marketing category ANDA
Marketing start 2015-03-04
Substance METHYLPHENIDATE HYDROCHLORIDE
Active strength 5 mg/5mL
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 43 .
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 A091601-001 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 A091601-002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 86 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 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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 Methylphenidate Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL
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 1091341 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 72162-2040-5 Methylphenidate Hydrochloride 500 mL in 1 BOTTLE, PLASTIC SOLUTION 500 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2040 METHYLPHENIDATE HYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK] 102 Current NDC, 1 package rows 20250316_ad3a3865-952e-46cf-8387-1228e2375312.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72162-2040-5 72162204005 500 mL in 1 BOTTLE, PLASTIC (72162-2040-5) 500 ml 2024-04-03 No No Current