Methadone Hydrochloride

Product NDC: 0054-0392
11-digit product format: 000540392
Labeler code: 0054
Product ID: 0054-0392_6cc1b9b7-bfbc-478b-a572-05a802018bda
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methadone Hydrochloride
Dosage form: CONCENTRATE
Route: ORAL
Labeler: Hikma Pharmaceuticals USA
Application: ANDA040180
Marketing category: ANDA
Marketing start: 2010-03-16
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
A040180-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA		1998-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040180-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040180-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	1998-04-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040180-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040180-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040180-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040180-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040180-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040180-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040180-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040180-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040180-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040180-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040180-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040180-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040180-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040180-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040180-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040180-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040180-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040180-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040180-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040180-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040180-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040180-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040180-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040180-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040180-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040180-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040180-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040180-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040180-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040180-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040180-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040180-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040180-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040180-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040180-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040180-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040180-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040180-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040180-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040180-001	AA	1	`e64feba35796…`

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
991147	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e72841bf-364b-49b1-8e69-7e26ddcd2657	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49b	Product name	3	20250819
a48f0261-b6cc-12b3-49fd-ed131bc5aa96	Product name	4	20210902
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9	Product name	6	20200708
a6a96832-f31d-b458-45cb-abb8bd940b44	Product name	2	20200304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-0392-68	Methadone Hydrochloride	1000 mL in 1 BOTTLE	CONCENTRATE	1000		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0392-68	ML - Milliliter	0054-0392	e7c2e19d-0fe2-49ed-a122-66a4fb188540	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHADONE HYDROCHLORIDE	ACTIVE INGREDIENT	229809935B	METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]	7
METHADONE	ACTIVE MOIETY	UC6VBE7V1Z	METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]	7
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]	7
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]	7
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]	7
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]	7
SORBITOL	INACTIVE INGREDIENT	506T60A25R	METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]	7
SUCROSE	INACTIVE INGREDIENT	C151H8M554	METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0392	METHADONE HYDROCHLORIDE CONCENTRATE [HIKMA PHARMACEUTICALS USA]	17	Current NDC, Legacy NDC, 1 package rows	20240601_e72841bf-364b-49b1-8e69-7e26ddcd2657.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	d7b30c78-c531-4dc5-9552-d68daa3210d1	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040180 application number: ANDA040180
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA	e72841bf-364b-49b1-8e69-7e26ddcd2657	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040180 application number: ANDA040180 ndc (product): 0054-0392

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
229809935B	METHADONE HYDROCHLORIDE	1095-90-5	METHADONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
991147	methadone HCl 10 MG in 1 mL Concentrate for Oral Solution	PSN	e72841bf-364b-49b1-8e69-7e26ddcd2657	18
991147	methadone hydrochloride 10 MG/ML Oral Solution	SCD	e72841bf-364b-49b1-8e69-7e26ddcd2657	18
991147	methadone hydrochloride 10 MG per 1 ML Oral Solution	SY	e72841bf-364b-49b1-8e69-7e26ddcd2657	18
991147	methadone hydrochloride 5 MG per 0.5 ML Oral Solution	SY	e72841bf-364b-49b1-8e69-7e26ddcd2657	18
991147	methadone HCl 10 MG in 1 mL Concentrate for Oral Solution	PSN	d7b30c78-c531-4dc5-9552-d68daa3210d1	6
991147	methadone hydrochloride 10 MG/ML Oral Solution	SCD	d7b30c78-c531-4dc5-9552-d68daa3210d1	6
991147	methadone hydrochloride 10 MG per 1 ML Oral Solution	SY	d7b30c78-c531-4dc5-9552-d68daa3210d1	6
991147	methadone hydrochloride 5 MG per 0.5 ML Oral Solution	SY	d7b30c78-c531-4dc5-9552-d68daa3210d1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0392-68	00054039268	1000 mL in 1 BOTTLE (0054-0392-68)	1000 ml	2010-03-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methadone Hydrochloride	ATLANTIC BIOLOGICALS CORP.	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	7
Methadone Hydrochloride - Hikma Pharmaceuticals USA \| West-Ward Columbus Inc.	Hikma Pharmaceuticals USA \| West-Ward Columbus Inc.	2026-03-03	HUMAN PRESCRIPTION DRUG LABEL	18
Methadone Hydrochloride Oral Concentrate USP (Cherry)	Precision Dose, Inc.	2021-03-18	HUMAN PRESCRIPTION DRUG LABEL	1