Home NDC 40032-570 Methylphenidate Hydrochloride
Product NDC 40032-570
11-digit product format 400320570
Labeler code 40032
Product ID 40032-570_7620b57a-02e8-4fe6-9cd1-0e07a6152636
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate Hydrochloride
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Novel Laboratories, Inc.
Application ANDA204115
Marketing category ANDA
Marketing start 2015-02-25
Marketing end 0000-00-00
Substance METHYLPHENIDATE HYDROCHLORIDE
Active strength 3 mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule CII
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record
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 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 40032-570-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 40032-570-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 40032-570-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 40032-570-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 40032-570-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 40032-570-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 40032-570-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 40032-570-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 40032-570-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 40032-570-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A204115-001 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 A204115-002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 A204115-003 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25
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 · 129 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 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204115-002 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET, CHEWABLE / ORAL 2015-02-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204115-003 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE / ORAL 2015-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204115-001 METHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET, CHEWABLE / ORAL 2015-02-25 301d65b070ca…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 40032-570-01 Methylphenidate Hydrochloride 100 in 1 BOTTLE TABLET, CHEWABLE 100 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHYLPHENIDATE HYDROCHLORIDE ACTIVE INGREDIENT 4B3SC438HI METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.] 3 METHYLPHENIDATE ACTIVE MOIETY 207ZZ9QZ49 METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.] 3 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.] 3 MALTOSE INACTIVE INGREDIENT XJ6S9RV06F METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.] 3 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40032-570 METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.] 5 Legacy NDC, 1 package rows 20191221_16508cc6-13c7-4088-927a-b7206eb7c633.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 Marketing start Marketing end Sample Exclude flag Status 40032-570-01 40032057001 100 TABLET, CHEWABLE in 1 BOTTLE (40032-570-01) 2015-02-25 0000-00-00 No No Current