Home NDC 43602-177 Methylphenidate Hydrochloride
Product NDC 43602-177
11-digit product format 436020177
Labeler code 43602
Product ID 43602-177_eadd6980-7aad-464b-9ce8-cf7b1a20064d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Ascent Pharmaceuticals, Inc.
Application ANDA207417
Marketing category ANDA
Marketing start 2021-01-29
Substance METHYLPHENIDATE
Active strength 5 mg/5mL
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207417-001 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 A207417-002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 72 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 2026-08-18 06:07:40 2026-07 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207417-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2021-01-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207417-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2021-01-29 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methylphenidate Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPHENIDATE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 207ZZ9QZ49 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1091133 Internal RxNorm lookup 1091341 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 43602-177-05 Methylphenidate Hydrochloride 500 mL in 1 BOTTLE SOLUTION 500 3 43602-177-25 Methylphenidate Hydrochloride 250 mL in 1 BOTTLE SOLUTION 250 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43602-177 METHYLPHENIDATE HYDROCHLORIDE SOLUTION [ASCENT PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20210219_45ebb59c-9603-4df6-b1be-3295ba2db1e7.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 43602-177-05 43602017705 500 mL in 1 BOTTLE (43602-177-05) 500 ml 2021-01-29 0000-00-00 No No Current 43602-177-25 43602017725 250 mL in 1 BOTTLE (43602-177-25) 250 ml 2021-01-29 0000-00-00 No No Current