Methadone Hydrochloride

Product NDC: 67457-217
11-digit product format: 674570217
Labeler code: 67457
Product ID: 67457-217_868dd5b8-2e28-475c-b6c3-bfc0a33fb793
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methadone Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Mylan Institutional LLC
Application: NDA021624
Marketing category: NDA
Marketing start: 2012-12-20
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: 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
N021624-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	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
N021624-001	AP

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	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021624-001	METHADONE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	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	N021624-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021624-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021624-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021624-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021624-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021624-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021624-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021624-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021624-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021624-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021624-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021624-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021624-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021624-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021624-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021624-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021624-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021624-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021624-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021624-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021624-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021624-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021624-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021624-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021624-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021624-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021624-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021624-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021624-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021624-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021624-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021624-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021624-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021624-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021624-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021624-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021624-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021624-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021624-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021624-001	AP	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
864714	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
092d78eb-6423-495c-bf0d-e6532bea7138	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
a48f0261-b6cc-12b3-49fd-ed131bc5aa96	Product name	4	20210902
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9	Product name	6	20200708
a6a96832-f31d-b458-45cb-abb8bd940b44	Product name	2	20200304
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67457-217-20	Methadone Hydrochloride	20 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	20		16
67457-217-20	Methadone Hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-217-20	ML - Milliliter	67457-217	6e37a4fe-c125-4e3b-a53c-7e9c1ef2cfd6	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 INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
Methadone	ACTIVE MOIETY	UC6VBE7V1Z	METHADONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
Chlorobutanol	INACTIVE INGREDIENT	HM4YQM8WRC	METHADONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	METHADONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
Sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	METHADONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	METHADONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-217	METHADONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	15	Current NDC, Legacy NDC, 2 package rows	20240430_092d78eb-6423-495c-bf0d-e6532bea7138.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Mylan Institutional LLC	092d78eb-6423-495c-bf0d-e6532bea7138	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021624 application number: NDA021624 ndc (product): 67457-217

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
864714	methadone HCl 10 MG/ML Injectable Solution	PSN	092d78eb-6423-495c-bf0d-e6532bea7138	16
864714	methadone hydrochloride 10 MG/ML Injectable Solution	SCD	092d78eb-6423-495c-bf0d-e6532bea7138	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-217-20	67457021720	1 VIAL, MULTI-DOSE in 1 CARTON (67457-217-20) / 20 mL in 1 VIAL, MULTI-DOSE	2012-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methadone Hydrochloride - Mylan Institutional LLC	Mylan Institutional LLC	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL	18