Home NDC 39328-154 Methylphenidate HCl
Product NDC 39328-154
11-digit product format 393280154
Labeler code 39328
Product ID 39328-154_604deb17-dd9e-4386-a52b-248b1d5cb6b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate HCl
Dosage form SOLUTION
Route ORAL
Labeler Patrin Pharma, Inc.
Application ANDA210764
Marketing category ANDA
Marketing start 2020-04-23
Substance METHYLPHENIDATE HYDROCHLORIDE
Active strength 10 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 42 .
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 A210764-001 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 A210764-002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10
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 2 · 76 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 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210764-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2020-04-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210764-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2020-04-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methylphenidate HCl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPHENIDATE HYDROCHLORIDE 10 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1091133 Internal RxNorm lookup 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 39328-154-50 Methylphenidate HCl 500 mL in 1 BOTTLE SOLUTION 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39328-154 METHYLPHENIDATE HCL SOLUTION [PATRIN PHARMA, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20200423_7d66dbf9-3966-4949-b7c9-d2ca8c7f3278.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 39328-154-50 39328015450 500 mL in 1 BOTTLE (39328-154-50) 500 ml 2020-04-23 0000-00-00 No No Current