Home NDC 31722-173 METHYLPHENIDATE HYDROCHLORIDE
Product NDC 31722-173
11-digit product format 317220173
Labeler code 31722
Product ID 31722-173_85610552-360d-4ae3-b160-0819534f8220
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHYLPHENIDATE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Camber Pharmaceutical Inc
Application ANDA207416
Marketing category ANDA
Marketing start 2015-10-01
Substance METHYLPHENIDATE HYDROCHLORIDE
Active strength 5 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 A207416-001 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 A207416-002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 A207416-003 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22
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 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207416-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-09-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207416-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-09-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207416-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-09-22 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 4 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 5 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 31722-173-01 METHYLPHENIDATE HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 9 31722-173-05 METHYLPHENIDATE HYDROCHLORIDE 500 in 1 BOTTLE TABLET 500 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-173 METHYLPHENIDATE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICAL INC] 8 Current NDC, Legacy NDC, 2 package rows 20241012_778190da-1528-4def-94bf-ee23ee5268a5.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 31722-173-01 31722017301 100 TABLET in 1 BOTTLE (31722-173-01) 100 tablet 2015-10-01 0000-00-00 No No Current 31722-173-05 31722017305 500 TABLET in 1 BOTTLE (31722-173-05) 500 tablet 2015-10-01 0000-00-00 No No Current