Methadone Hydrochloride

Product NDC: 68094-031
11-digit product format: 680940031
Labeler code: 68094
Product ID: 68094-031_b9e6a3ca-9559-4dfa-b742-646be5def826
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methadone Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Precision Dose, Inc.
Application: ANDA087393
Marketing category: ANDA
Marketing start: 2020-12-23
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: 2026-12-31
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
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 · 42 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
2026-08-18 06:07:40	2026-07	A087393-001	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RLD, RS, Approved before 1982	`caaa826d4ba7…`
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…`

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	A087393-001	AA	1	`caaa826d4ba7…`
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…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
864761	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
cbc42334-8783-4572-b8da-8c7451d14077	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	SPL version
68094-031-59	Methadone Hydrochloride	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	5
68094-031-62	Methadone Hydrochloride	3 in 1 CASE	SOLUTION	3	5
68094-031-62	Methadone Hydrochloride	10 in 1 TRAY	SOLUTION	10	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-031-59	ML - Milliliter	68094-031	8e9c7997-5540-4e74-9109-5e1d9f59156a	1	2021-01-08
68094-031-62	ML - Milliliter	68094-031	0b1f1f24-d1bc-413c-be19-34625eeab428	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68094-031	METHADONE HYDROCHLORIDE SOLUTION [PRECISION DOSE, INC.]	4	Current NDC, Legacy NDC, 3 package rows	20250305_cbc42334-8783-4572-b8da-8c7451d14077.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
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 ndc (product): 68094-031
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
864761	methadone HCl 5 MG in 5 mL Oral Solution	PSN	cbc42334-8783-4572-b8da-8c7451d14077	5
864761	methadone hydrochloride 1 MG/ML Oral Solution	SCD	cbc42334-8783-4572-b8da-8c7451d14077	5
864761	methadone HCl 5 MG per 5 ML Oral Solution	SY	cbc42334-8783-4572-b8da-8c7451d14077	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68094-031-59	68094003159	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
68094-031-62	68094003162	3 TRAY in 1 CASE (68094-031-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-031-59)	3 tray	2020-12-23	0000-00-00	No	No	Current