Methadone Hydrocloride

Product NDC: 72162-1085
11-digit product format: 721621085
Labeler code: 72162
Product ID: 72162-1085_7dbaf38c-adfb-4540-add1-cf94e2e1885d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methadone hydrochloride
Dosage form: CONCENTRATE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA212093
Marketing category: ANDA
Marketing start: 2020-11-02
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
A212093-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA		2020-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212093-001	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.

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	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212093-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212093-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212093-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212093-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212093-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212093-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212093-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212093-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212093-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212093-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212093-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212093-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212093-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212093-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212093-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212093-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212093-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212093-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212093-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212093-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212093-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212093-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212093-001	AA	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212093-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212093-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212093-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212093-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212093-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212093-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212093-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212093-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212093-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212093-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212093-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212093-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212093-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212093-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methadone Hydrocloride
Brand name suffix: dye-free, sugar-free, unflavored
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
714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe	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
72162-1085-2	Methadone Hydrocloridedye-free, sugar-free, unflavored	30 mL in 1 BOTTLE, PLASTIC	CONCENTRATE	30		104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1085-2	ML - Milliliter	72162-1085	ea869c11-e656-4a1e-b025-bb0cac30ac4b	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1085	METHADONE HYDROCLORIDE DYE-FREE, SUGAR-FREE, UNFLAVORED (METHADONE HYDROCHLORIDE) CONCENTRATE [BRYANT RANCH PREPACK]	103	Current NDC, 1 package rows	20241122_714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe.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 Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Bryant Ranch Prepack	714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212093 application number: ANDA212093 ndc (product): 72162-1085
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Bryant Ranch Prepack	f9dad5d5-3417-4992-99ee-6550f81add6b	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212093 application number: ANDA212093
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Lannett Company, Inc.	0955ea4a-c6b8-431f-ba42-9641b5b102ea	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212093 application number: ANDA212093
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Atlantic Biologicals Corp.	373c649e-798d-770e-e063-6294a90a6e47	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212093 application number: ANDA212093

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	714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe	104
991147	methadone hydrochloride 10 MG/ML Oral Solution	SCD	714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe	104
991147	methadone hydrochloride 10 MG per 1 ML Oral Solution	SY	714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe	104
991147	methadone hydrochloride 5 MG per 0.5 ML Oral Solution	SY	714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1085-2	72162108502	30 mL in 1 BOTTLE, PLASTIC (72162-1085-2)	30 ml	2023-10-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methadone Hydrocloride dye-free, sugar-free, unflavored - Bryant Ranch Prepack	Bryant Ranch Prepack	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	104