Home NDC 0641-6266 Methadone Hydrochloride
Product NDC 0641-6266
11-digit product format 006416266
Labeler code 0641
Product ID 0641-6266_821743df-67de-46a9-92c5-b530047a3192
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA218609
Marketing category ANDA
Marketing start 2025-06-12
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218609-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2025-05-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218609-001 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.
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 2026-02-19 14:30 UTC 2026-02 A218609-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2025-05-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218609-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2025-05-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218609-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2025-05-05 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218609-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2025-05-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218609-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218609-001 AP 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218609-001 AP 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218609-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Methadone Hydrochloride
Listing expiration 2026-12-31 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 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 0641-6266-01 Methadone Hydrochloride 1 in 1 CARTON INJECTION 1 1 0641-6266-01 Methadone Hydrochloride 20 mL in 1 VIAL, MULTI-DOSE INJECTION 20 1
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 0641-6266-01 00641626601 1 VIAL, MULTI-DOSE in 1 CARTON (0641-6266-01) / 20 mL in 1 VIAL, MULTI-DOSE 2025-06-12 No No Current