Methadone Hydrochloride

Product NDC: 70166-284
Requested package NDC: 70166-284-01
11-digit product format: 701660284
Labeler code: 70166
Product ID: 70166-284_923a3dd2-b856-f053-e053-2995a90a8204
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methadone Hydrochloride
Dosage form: CONCENTRATE
Route: ORAL
Labeler: Lohxa
Application: ANDA089897
Marketing category: ANDA
Marketing start: 1988-04-30
Marketing end: 0000-00-00
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70166-284	70166-284-01	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A089897-001	METHADONE HYDROCHLORIDE INTENSOL	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA		1988-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089897-001	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	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`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	A089897-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089897-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089897-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089897-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089897-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089897-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089897-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089897-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089897-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089897-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089897-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089897-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089897-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089897-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089897-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089897-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089897-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089897-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089897-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089897-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089897-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089897-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089897-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089897-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089897-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089897-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089897-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089897-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089897-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089897-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089897-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089897-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089897-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089897-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089897-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089897-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089897-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089897-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089897-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089897-001	AA	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70166-284-01	2023-01-30	C162847	48780-1	f386c649-bd74-0266-e053-dadaa90a7c1a	Methadone Hydrochloride Oral Concentrate USP CII, 10 mg per mL (Dye-Free, Sugar-Free, Unflavored)
70166-284-02	2023-01-30	C162847	48780-1	f386c649-bd74-0266-e053-dadaa90a7c1a	Methadone Hydrochloride Oral Concentrate USP CII, 10 mg per mL (Dye-Free, Sugar-Free, Unflavored)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70166-284-01	Methadone Hydrochloride	30 in 1 BOX	CONCENTRATE	30	2
70166-284-01	Methadone Hydrochloride	1 in 1 BAG	CONCENTRATE	1	2
70166-284-02	Methadone Hydrochloride	1 in 1 BAG	CONCENTRATE	1	2
70166-284-02	Methadone Hydrochloride	30 in 1 BOX	CONCENTRATE	30	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70166-284	METHADONE HYDROCHLORIDE CONCENTRATE [LOHXA]	2	Legacy NDC, 4 package rows	20190911_9804a4b6-51cd-40f8-84eb-e9655b50ee04.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	Hikma Pharmaceuticals USA Inc.	d0e6a966-179a-45e0-8444-4c1b8523f8d2	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089897 application number: ANDA089897
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): 089897 application number: ANDA089897

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	9804a4b6-51cd-40f8-84eb-e9655b50ee04	2
991147	methadone hydrochloride 10 MG/ML Oral Solution	SCD	9804a4b6-51cd-40f8-84eb-e9655b50ee04	2
991147	methadone hydrochloride 10 MG per 1 ML Oral Solution	SY	9804a4b6-51cd-40f8-84eb-e9655b50ee04	2
991147	methadone hydrochloride 5 MG per 0.5 ML Oral Solution	SY	9804a4b6-51cd-40f8-84eb-e9655b50ee04	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70166-284-01	70166028401	30 BAG in 1 BOX (70166-284-01) > 1 SYRINGE in 1 BAG > 1 mL in 1 SYRINGE	30 bag	2018-02-22	0000-00-00	No	No	Current