Home NDC 67877-618-33 Methylphenidate Hydrochloride
Product NDC 67877-618
Requested package NDC 67877-618-33
11-digit product format 678770618
Labeler code 67877
Product ID 67877-618_c6ff917f-4793-4098-b8b8-e1b31f10677b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA211779
Marketing category ANDA
Marketing start 2019-10-06
Substance METHYLPHENIDATE HYDROCHLORIDE
Active strength 20 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 67877-618 67877-618-33 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A211779-001 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 A211779-002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 A211779-003 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04
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 · 123 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 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211779-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-10-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211779-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2019-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211779-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-10-04 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 20 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 67877-618-01 2022-09-07 These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955 67877-618-33 2022-09-07 These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955 67877-618-01 2022-07-29 These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955 67877-618-33 2022-07-29 These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67877-618-01 Methylphenidate Hydrochloride 100 in 1 BOTTLE TABLET 100 9 67877-618-33 Methylphenidate Hydrochloride 1 in 1 BLISTER PACK TABLET 1 9 67877-618-33 Methylphenidate Hydrochloride 10 in 1 CARTON TABLET 10 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-618 METHYLPHENIDATE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 9 Current NDC, Legacy NDC, 3 package rows 20240716_8e97c9f3-956c-416a-a7c2-68bb92053ce5.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 67877-618-33 67877061833 10 BLISTER PACK in 1 CARTON (67877-618-33) / 1 TABLET in 1 BLISTER PACK 10 blister pack 2019-10-06 0000-00-00 No No Current