Methadone Hydrochloride

Product NDC: 0054-3555
11-digit product format: 000543555
Labeler code: 0054
Product ID: 0054-3555_02c36c8d-ac85-4274-bf54-532c83f57396
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methadone Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA087393
Marketing category: ANDA
Marketing start: 1981-05-22
Substance: METHADONE HYDROCHLORIDE
Active strength: 5 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
A087393-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087393-001	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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087393-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087393-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087393-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087393-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087393-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087393-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087393-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087393-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087393-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087393-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087393-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087393-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087393-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087393-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087393-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087393-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087393-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087393-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087393-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087393-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087393-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087393-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087393-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087393-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087393-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087393-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087393-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087393-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087393-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087393-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087393-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087393-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087393-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087393-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087393-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087393-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087393-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087393-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087393-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087393-001	AA	1	`cb3db0bc1861…`

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	5 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8c363f90-c378-48ae-abbc-aeb25c9bf5cb	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
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
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-3555-63	Methadone Hydrochloride	500 mL in 1 BOTTLE	SOLUTION	500		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-3555-63	ML - Milliliter	0054-3555	1ed14a04-a048-4d51-b75a-166fac2f3928	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 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
0054-3555	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	8c363f90-c378-48ae-abbc-aeb25c9bf5cb	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087393 application number: ANDA087393 ndc (product): 0054-3555
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Precision Dose, Inc.	cbc42334-8783-4572-b8da-8c7451d14077	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087393 application number: ANDA087393
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	American Health Packaging	f935effe-e5b2-4bf7-bbde-6e80bb99076f	2025-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087393 application number: ANDA087393
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Precision Dose, Inc.	e980d666-d74d-4358-a3b7-c6accb15eba6	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087393 application number: ANDA087393

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
864769	methadone HCl 10 MG in 5 mL Oral Solution	PSN	8c363f90-c378-48ae-abbc-aeb25c9bf5cb	23
864761	methadone HCl 5 MG in 5 mL Oral Solution	PSN	8c363f90-c378-48ae-abbc-aeb25c9bf5cb	23
864761	methadone hydrochloride 1 MG/ML Oral Solution	SCD	8c363f90-c378-48ae-abbc-aeb25c9bf5cb	23
864769	methadone hydrochloride 2 MG/ML Oral Solution	SCD	8c363f90-c378-48ae-abbc-aeb25c9bf5cb	23
864761	methadone HCl 5 MG per 5 ML Oral Solution	SY	8c363f90-c378-48ae-abbc-aeb25c9bf5cb	23
864769	methadone hydrochloride 10 MG per 5 ML Oral Solution	SY	8c363f90-c378-48ae-abbc-aeb25c9bf5cb	23
864769	methadone HCl 10 MG in 5 mL Oral Solution	PSN	c3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb	15
864761	methadone HCl 5 MG in 5 mL Oral Solution	PSN	c3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb	15
864761	methadone hydrochloride 1 MG/ML Oral Solution	SCD	c3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb	15
864769	methadone hydrochloride 2 MG/ML Oral Solution	SCD	c3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb	15
864761	methadone HCl 5 MG per 5 ML Oral Solution	SY	c3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb	15
864769	methadone hydrochloride 10 MG per 5 ML Oral Solution	SY	c3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb	15
864761	methadone HCl 5 MG in 5 mL Oral Solution	PSN	cbc42334-8783-4572-b8da-8c7451d14077	5
864761	methadone HCl 5 MG in 5 mL Oral Solution	PSN	eff99966-a35c-4952-a9aa-1344da90b9eb	5
864761	methadone hydrochloride 1 MG/ML Oral Solution	SCD	cbc42334-8783-4572-b8da-8c7451d14077	5
864761	methadone hydrochloride 1 MG/ML Oral Solution	SCD	eff99966-a35c-4952-a9aa-1344da90b9eb	5
864761	methadone HCl 5 MG per 5 ML Oral Solution	SY	eff99966-a35c-4952-a9aa-1344da90b9eb	5
864761	methadone HCl 5 MG per 5 ML Oral Solution	SY	cbc42334-8783-4572-b8da-8c7451d14077	5
864761	methadone HCl 5 MG in 5 mL Oral Solution	PSN	f935effe-e5b2-4bf7-bbde-6e80bb99076f	3
864761	methadone hydrochloride 1 MG/ML Oral Solution	SCD	f935effe-e5b2-4bf7-bbde-6e80bb99076f	3
864761	methadone HCl 5 MG per 5 ML Oral Solution	SY	f935effe-e5b2-4bf7-bbde-6e80bb99076f	3
864761	methadone HCl 5 MG in 5 mL Oral Solution	PSN	e980d666-d74d-4358-a3b7-c6accb15eba6	2
864761	methadone hydrochloride 1 MG/ML Oral Solution	SCD	e980d666-d74d-4358-a3b7-c6accb15eba6	2
864761	methadone HCl 5 MG per 5 ML Oral Solution	SY	e980d666-d74d-4358-a3b7-c6accb15eba6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-3555-63	00054355563	500 mL in 1 BOTTLE (0054-3555-63)	500 ml	1981-05-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methadone Hydrochloride	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc. \| Siegfried USA LLC	2025-12-05	HUMAN PRESCRIPTION DRUG LABEL	23
Methadone Hydrochloride	Precision Dose, Inc.	2025-11-05	HUMAN PRESCRIPTION DRUG LABEL	5
Methadone Hydrochloride	American Health Packaging	2025-05-13	HUMAN PRESCRIPTION DRUG LABEL	3
Methadone Hydrochloride	Precision Dose, Inc.	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	2
Methadone Hydrochloride	ATLANTIC BIOLOGICALS CORP.	2024-05-20	HUMAN PRESCRIPTION DRUG LABEL	5
Methadone Hydrochloride	ATLANTIC BIOLOGICALS CORP.	2023-11-02	HUMAN PRESCRIPTION DRUG LABEL	15