Home NDC 0054-3556 Methadone Hydrochloride
Product NDC 0054-3556
11-digit product format 000543556
Labeler code 0054
Product ID 0054-3556_02c36c8d-ac85-4274-bf54-532c83f57396
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA087997
Marketing category ANDA
Marketing start 1982-08-30
Substance METHADONE HYDROCHLORIDE
Active strength 10 mg/5mL
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 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 A087997-001 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A087997-001 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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RS 1982-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A087997-001 METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 1982-08-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 10 mg/5mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864761 Internal RxNorm lookup 864769 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 0054-3556-63 Methadone Hydrochloride 500 mL in 1 BOTTLE SOLUTION 500 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHADONE HYDROCHLORIDE ACTIVE INGREDIENT 229809935B METHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 5 METHADONE ACTIVE MOIETY UC6VBE7V1Z METHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 5 ALCOHOL INACTIVE INGREDIENT 3K9958V90M METHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 5 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL METHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 5 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM METHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 5 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA METHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 METHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX METHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 5 SORBITOL INACTIVE INGREDIENT 506T60A25R METHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.] 5 METHADONE HYDROCHLORIDE ACTIVE INGREDIENT 229809935B METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 METHADONE ACTIVE MOIETY UC6VBE7V1Z METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-3556 METHADONE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 20 Current NDC, Legacy NDC, 1 package rows 20240619_8c363f90-c378-48ae-abbc-aeb25c9bf5cb.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 Units Marketing start Marketing end Sample Exclude flag Status 0054-3556-63 00054355663 500 mL in 1 BOTTLE (0054-3556-63) 500 ml 1982-08-30 0000-00-00 No No Current