Home NDC 81298-7500 Methadone Hydrochloride
Product NDC 81298-7500
11-digit product format 812987500
Labeler code 81298
Product ID 81298-7500_46a3297c-98d2-48ef-a7a9-9776ed80e0bd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Long Grove Pharmaceuticals, LLC
Application ANDA208306
Marketing category ANDA
Marketing start 2025-06-28
Substance METHADONE HYDROCHLORIDE
Active strength 200 mg/20mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208306-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208306-001 AP
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 · 42 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 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208306-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2017-10-27 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methadone Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHADONE HYDROCHLORIDE 200 mg/20mL
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 864714 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 81298-7500-1 Methadone Hydrochloride 1 in 1 CARTON INJECTION 1 2 81298-7500-1 Methadone Hydrochloride 20 mL in 1 VIAL, GLASS INJECTION 20 2
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 Sample Exclude flag Status 81298-7500-1 81298750001 1 VIAL, GLASS in 1 CARTON (81298-7500-1) / 20 mL in 1 VIAL, GLASS 2025-06-28 No No Current