Home NDC 27808-059 Methylphenidate Hydrochloride
Product NDC 27808-059
11-digit product format 278080059
Labeler code 27808
Product ID 27808-059_2b5b76ed-a330-4f7b-a111-467a067ee663
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Cranbury Pharmaceuticals, LLC
Application ANDA091601
Marketing category ANDA
Marketing start 2015-03-04
Substance METHYLPHENIDATE HYDROCHLORIDE
Active strength 10 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 1 .
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 A091601-001 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 A091601-002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23
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 2 of 3 · 82 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 2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 e64feba35796…2022-09-29 23:25 UTC 2022-09 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091601-001 METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA 2010-07-23 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091601-002 METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA 2010-07-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 HYDROCHLORIDE 10 mg/5mL
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 · 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 27808-059-01 Methylphenidate Hydrochloride 500 mL in 1 BOTTLE, PLASTIC SOLUTION 500 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27808-059 METHYLPHENIDATE HYDROCHLORIDE SOLUTION [CRANBURY PHARMACEUTICALS, LLC] 22 Current NDC, Legacy NDC, 1 package rows 20250326_e817377f-bc72-415a-acd2-7136746b2479.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 27808-059-01 27808005901 500 mL in 1 BOTTLE, PLASTIC (27808-059-01) 500 ml 2015-03-04 0000-00-00 No No Current