Home NDC 51991-002 Methadone Hydrochloride
Product NDC 51991-002
11-digit product format 519910002
Labeler code 51991
Product ID 51991-002_eec50ad6-d9ae-42df-ae5e-9cd75199148e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Breckenridge Pharmaceutical Inc
Application ANDA218252
Marketing category ANDA
Marketing start 2024-12-30
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 A218252-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218252-001 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 A218252-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218252-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218252-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218252-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218252-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218252-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-16 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218252-001 METHADONE HYDROCHLORIDE 10MG/ML INJECTABLE / INJECTION AP 2024-12-16 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 51991-002-98 Methadone Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 2 51991-002-98 Methadone Hydrochloride 20 mL in 1 VIAL, GLASS INJECTION, SOLUTION 20 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51991-002 METHADONE HYDROCHLORIDE INJECTION, SOLUTION [BRECKENRIDGE PHARMACEUTICAL INC] 1 Current NDC, 2 package rows 20241231_13541167-95f4-4cb9-9d7d-3c1aced5c5f6.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 Marketing start Sample Exclude flag Status 51991-002-98 51991000298 1 VIAL, GLASS in 1 CARTON (51991-002-98) / 20 mL in 1 VIAL, GLASS 2024-12-30 No No Current