Home NDC 0527-1927 Methadone Hydrocloride
Product NDC 0527-1927
11-digit product format 005271927
Labeler code 0527
Product ID 0527-1927_127a6533-e403-48b1-9592-5a90d5cf155e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methadone hydrochloride
Dosage form CONCENTRATE
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA212093
Marketing category ANDA
Marketing start 2020-11-02
Substance METHADONE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212093-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212093-001 AA
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.
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 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212093-001 METHADONE HYDROCHLORIDE 10MG/ML CONCENTRATE / ORAL AA 2020-11-02 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Methadone Hydrocloride
Brand name suffix dye-free, sugar-free, unflavored
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHADONE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 229809935B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 991147 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 0527-1927-36 Methadone Hydrocloridedye-free, sugar-free, unflavored 1 in 1 CARTON CONCENTRATE 1 20 0527-1927-36 Methadone Hydrocloridedye-free, sugar-free, unflavored 30 mL in 1 BOTTLE, PLASTIC CONCENTRATE 30 20 0527-1927-39 Methadone Hydrocloridedye-free, sugar-free, unflavored 1000 mL in 1 BOTTLE, PLASTIC CONCENTRATE 1000 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1927 METHADONE HYDROCLORIDE DYE-FREE, SUGAR-FREE, UNFLAVORED (METHADONE HYDROCHLORIDE) CONCENTRATE [LANNETT COMPANY, INC.] 18 Current NDC, Legacy NDC, 3 package rows 20241024_0955ea4a-c6b8-431f-ba42-9641b5b102ea.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Methadone Hydrocloride dye-free, sugar-free, unflavored METHADONE HYDROCHLORIDE Bryant Ranch Prepack 714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe 2026-04-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212093 application number: ANDA212093 Methadone Hydrocloride dye-free, sugar-free, unflavored METHADONE HYDROCHLORIDE Bryant Ranch Prepack f9dad5d5-3417-4992-99ee-6550f81add6b 2026-03-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212093 application number: ANDA212093 Methadone Hydrocloride dye-free, sugar-free, unflavored METHADONE HYDROCHLORIDE Lannett Company, Inc. 0955ea4a-c6b8-431f-ba42-9641b5b102ea 2026-01-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212093 application number: ANDA212093 ndc (product): 0527-1927 Methadone Hydrocloride dye-free, sugar-free, unflavored METHADONE HYDROCHLORIDE Atlantic Biologicals Corp. 373c649e-798d-770e-e063-6294a90a6e47 2025-05-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212093 application number: ANDA212093
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 0527-1927-36 00527192736 1 BOTTLE, PLASTIC in 1 CARTON (0527-1927-36) / 30 mL in 1 BOTTLE, PLASTIC 2020-11-02 0000-00-00 No No Current 0527-1927-39 00527192739 1000 mL in 1 BOTTLE, PLASTIC (0527-1927-39) 1000 ml 2020-11-02 0000-00-00 No No Current