Home NDC 31722-928 Methylphenidate Hydrochloride
Product NDC 31722-928
11-digit product format 317220928
Labeler code 31722
Product ID 31722-928_3547512f-45f7-4c6a-8fb0-2144eff24b11
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate Hydrochloride
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Camber Pharmaceuticals Inc.
Application ANDA210354
Marketing category ANDA
Marketing start 2018-03-01
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 2027-12-31
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 A210354-001 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 A210354-002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 A210354-003 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29
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 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210354-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210354-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL AB RS 2017-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210354-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL AB 2017-12-29 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 2027-12-31 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 1091152 Internal RxNorm lookup 1091322 Internal RxNorm lookup 1091389 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 31722-928-01 Methylphenidate Hydrochloride 100 in 1 BOTTLE TABLET, CHEWABLE 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-928 METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [CAMBER PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 1 package rows 20231011_bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e0.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 Marketing start Marketing end Sample Exclude flag Status 31722-928-01 31722092801 100 TABLET, CHEWABLE in 1 BOTTLE (31722-928-01) 2018-03-01 0000-00-00 No No Current