Home NDC 43386-573 Methylphenidate Hydrochloride
Product NDC 43386-573
11-digit product format 433860573
Labeler code 43386
Product ID 43386-573_ac26e6b6-2be0-458d-8acc-d963bcca13a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA207884
Marketing category ANDA
Marketing start 2016-01-20
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 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207884-001 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 A207884-002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 A207884-003 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13
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 · 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 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207884-002 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-11-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207884-003 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET / ORAL AB 2015-11-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207884-001 METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-11-13 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 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 43386-573-01 Methylphenidate Hydrochloride 100 in 1 BOTTLE TABLET 100 8 43386-573-03 Methylphenidate Hydrochloride 30 in 1 BOTTLE TABLET 30 8 43386-573-05 Methylphenidate Hydrochloride 500 in 1 BOTTLE TABLET 500 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-573 METHYLPHENIDATE HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS,INC.] 8 Current NDC, Legacy NDC, 3 package rows 20240322_ec8a8896-077d-4dee-9e10-97172512c5ed.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 43386-573-01 43386057301 100 TABLET in 1 BOTTLE (43386-573-01) 100 tablet 2016-01-20 0000-00-00 No No Current 43386-573-03 43386057303 30 in 1 BOTTLE Historical 43386-573-05 43386057305 500 TABLET in 1 BOTTLE (43386-573-05) 500 tablet 2016-01-20 0000-00-00 No No Current 43386-573-30 43386057330 30 TABLET in 1 BOTTLE (43386-573-30) 30 tablet 2016-01-20 0000-00-00 No No Current