Home NDC 13811-700-30 Methylphenidate Hydrochloride
Product NDC 13811-700
Requested package NDC 13811-700-30
11-digit product format 138110700
Labeler code 13811
Product ID 13811-700_ba649db4-df0d-4587-8370-3f866e66e54b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate hydrochloride
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Trigen Laboratories, LLC
Application NDA216117
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-06-23
Substance METHYLPHENIDATE HYDROCHLORIDE
Active strength 63 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 43 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216117-001 RELEXXII METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 N216117-002 RELEXXII METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 N216117-003 RELEXXII METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 N216117-004 RELEXXII METHYLPHENIDATE HYDROCHLORIDE 45MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 N216117-005 RELEXXII METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 N216117-006 RELEXXII METHYLPHENIDATE HYDROCHLORIDE 63MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 N216117-007 RELEXXII METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-23
Orange Book patents# Current patent rows page 1 of 1 · 35 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 6 · 210 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 N216117-001 RELEXXII 18MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-002 RELEXXII 27MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-003 RELEXXII 36MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-004 RELEXXII 45MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-005 RELEXXII 54MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-006 RELEXXII 63MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-007 RELEXXII 72MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216117-001 RELEXXII 18MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216117-002 RELEXXII 27MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216117-003 RELEXXII 36MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216117-004 RELEXXII 45MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216117-005 RELEXXII 54MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216117-006 RELEXXII 63MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216117-007 RELEXXII 72MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216117-001 RELEXXII 18MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216117-002 RELEXXII 27MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216117-003 RELEXXII 36MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216117-004 RELEXXII 45MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216117-005 RELEXXII 54MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216117-006 RELEXXII 63MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216117-007 RELEXXII 72MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216117-001 RELEXXII 18MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216117-002 RELEXXII 27MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216117-003 RELEXXII 36MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216117-004 RELEXXII 45MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216117-005 RELEXXII 54MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216117-006 RELEXXII 63MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216117-007 RELEXXII 72MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216117-001 RELEXXII 18MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216117-002 RELEXXII 27MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216117-003 RELEXXII 36MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216117-004 RELEXXII 45MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216117-005 RELEXXII 54MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216117-006 RELEXXII 63MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216117-007 RELEXXII 72MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216117-001 RELEXXII 18MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216117-002 RELEXXII 27MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216117-003 RELEXXII 36MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216117-004 RELEXXII 45MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216117-005 RELEXXII 54MG TABLET, EXTENDED RELEASE / ORAL RLD 2022-06-23 fd3edfee7708…
Observed Orange Book patent history# Patent history page 1 of 9 · 350 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N216117-001 10265308 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-001 10695336 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-001 9707217 2037-02-03 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-001 9827234 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-001 9855258 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-002 10265308 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-002 10695336 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-002 9707217 2037-02-03 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-002 9827234 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-002 9855258 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-003 10265308 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-003 10695336 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-003 9707217 2037-02-03 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-003 9827234 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-003 9855258 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-004 10265308 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-004 10695336 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-004 9707217 2037-02-03 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-004 9827234 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-004 9855258 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-005 10265308 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-005 10695336 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-005 9707217 2037-02-03 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-005 9827234 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-005 9855258 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-006 10265308 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-006 10695336 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-006 9707217 2037-02-03 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-006 9827234 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-006 9855258 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-007 10265308 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-007 10695336 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-007 9707217 2037-02-03 Drug product 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-007 9827234 2037-02-03 U-4032 2024-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216117-007 9855258 2037-02-03 U-4032 Drug product 2024-11-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216117-001 10265308 2037-02-03 U-4032 Drug product 2024-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216117-001 10695336 2037-02-03 U-4032 2024-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216117-001 9707217 2037-02-03 Drug product 2024-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216117-001 9827234 2037-02-03 U-4032 2024-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216117-001 9855258 2037-02-03 U-4032 Drug product 2024-11-18 caaa826d4ba7…
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 63 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2605796 Internal RxNorm lookup 2605798 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 13811-700-30 Methylphenidate Hydrochloride 30 in 1 BOTTLE TABLET, EXTENDED RELEASE 30 48
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13811-700 METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [TRIGEN LABORATORIES, LLC] 46 Current NDC, Legacy NDC, 1 package rows 20231121_dd8d7b6e-c23d-4e16-bb53-959e9127ebc6.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 Marketing start Marketing end Sample Exclude flag Status 13811-700-30 13811070030 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-700-30) 2022-06-23 0000-00-00 No No Current