METHADONE HYDROCHLORIDE

Product NDC: 0904-7417
11-digit product format: 009047417
Labeler code: 0904
Product ID: 0904-7417_51c895c4-90fb-4d88-9032-beea257bec6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METHADONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA088109
Marketing category: ANDA
Marketing start: 2024-01-03
Substance: METHADONE HYDROCHLORIDE
Active strength: 10 mg/1
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088109-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		1983-03-08
A088109-002	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA		1983-03-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A088109-001	AA
A088109-002	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 · 45 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
2026-02-19 14:30 UTC	2026-02	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088109-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1983-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088109-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1983-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088109-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1983-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`3a93d1ddd44b…`

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	A088109-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088109-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088109-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088109-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088109-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088109-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088109-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088109-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088109-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088109-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088109-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088109-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088109-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088109-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088109-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088109-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088109-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088109-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088109-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088109-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A088109-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088109-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088109-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088109-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088109-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088109-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088109-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088109-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088109-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088109-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088109-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088109-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088109-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088109-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088109-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088109-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088109-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088109-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088109-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088109-001	AA	1	`a50c72e98297…`

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/1

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
864706	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
db52fdc0-765a-4fad-a8f9-ef98c6e4b898	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
0904-7417-61	METHADONE HYDROCHLORIDE	1 in 1 BLISTER PACK	TABLET	1		4
0904-7417-61	METHADONE HYDROCHLORIDE	100 in 1 CARTON	TABLET	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7417-61	EA - Each	0904-7417	9c718a73-e0d8-408a-9748-a3ed16cb1a77	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7417	METHADONE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	2	Current NDC, 2 package rows	20250406_db52fdc0-765a-4fad-a8f9-ef98c6e4b898.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	Major Pharmaceuticals	db52fdc0-765a-4fad-a8f9-ef98c6e4b898	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088109 application number: ANDA088109 ndc (product): 0904-7417
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	50f14803-78c0-4d19-8b5d-9a9c17582ac1	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088109 application number: ANDA088109

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
864706	methadone HCl 10 MG Oral Tablet	PSN	db52fdc0-765a-4fad-a8f9-ef98c6e4b898	4
864706	methadone hydrochloride 10 MG Oral Tablet	SCD	db52fdc0-765a-4fad-a8f9-ef98c6e4b898	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7417-61	00904741761	100 BLISTER PACK in 1 CARTON (0904-7417-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2024-01-03	No	No	Current