Home NDC 57664-229 Methylphenidate Hydrochloride
Product NDC 57664-229
11-digit product format 576640229
Labeler code 57664
Product ID 57664-229_2f1c1df8-491a-08c9-e063-6394a90a1d06
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA090710
Marketing category ANDA
Marketing start 2013-08-16
Substance METHYLPHENIDATE HYDROCHLORIDE
Active strength 10 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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090710-001 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 A090710-002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 A090710-003 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 132 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 2026-10-15 13:18:30 2026-09 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090710-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090710-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2012-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090710-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-03-15 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 4 · 132 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 10 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1091150 Internal RxNorm lookup 1091392 Internal RxNorm lookup 1091497 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 57664-229-08 Methylphenidate Hydrochloride 100 in 1 BOTTLE TABLET 100 16 57664-229-13 Methylphenidate Hydrochloride 500 in 1 BOTTLE TABLET 500 16 57664-229-18 Methylphenidate Hydrochloride 1000 in 1 BOTTLE TABLET 1000 16 57664-229-83 Methylphenidate Hydrochloride 30 in 1 BOTTLE TABLET 30 16 57664-229-88 Methylphenidate Hydrochloride 100 in 1 BOTTLE TABLET 100 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHYLPHENIDATE HYDROCHLORIDE ACTIVE INGREDIENT 4B3SC438HI METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 METHYLPHENIDATE ACTIVE MOIETY 207ZZ9QZ49 METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57664-229 METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 16 Current NDC, Legacy NDC, 5 package rows 20250228_1a89b390-0cd5-45cb-9e70-20de44652c56.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 Marketing end Sample Exclude flag Status 57664-229-08 57664022908 100 TABLET in 1 BOTTLE (57664-229-08) 100 tablet 2013-08-16 0000-00-00 No No Current 57664-229-13 57664022913 500 TABLET in 1 BOTTLE (57664-229-13) 500 tablet 2013-08-16 0000-00-00 No No Current 57664-229-18 57664022918 1000 TABLET in 1 BOTTLE (57664-229-18) 1000 tablet 2013-08-16 0000-00-00 No No Current 57664-229-83 57664022983 30 TABLET in 1 BOTTLE (57664-229-83) 30 tablet 2013-08-16 0000-00-00 No No Current 57664-229-88 57664022988 100 TABLET in 1 BOTTLE (57664-229-88) 100 tablet 2013-08-16 0000-00-00 No No Current