METHADONE HYDROCHLORIDE

Product NDC: 63629-1027
11-digit product format: 636291027
Labeler code: 63629
Product ID: 63629-1027_c513c20b-ef58-4df1-8cce-ab397ef8e67c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METHADONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090635
Marketing category: ANDA
Marketing start: 2012-01-16
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-1027		D	Discontinued by firm		2026-08-03
excluded package	package	63629-1027	63629-1027-1	D	Discontinued by firm		2026-08-03

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
A090635-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2009-11-25
A090635-002	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA		2020-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090635-001	AA
A090635-002	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 · 78 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	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090635-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2020-09-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090635-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-11-25	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A090635-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090635-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090635-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090635-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090635-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090635-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090635-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090635-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090635-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090635-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090635-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090635-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090635-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090635-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090635-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090635-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090635-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090635-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090635-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090635-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090635-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090635-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090635-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090635-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090635-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090635-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090635-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090635-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090635-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090635-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090635-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090635-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090635-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090635-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090635-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090635-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090635-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090635-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090635-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090635-001	AA	1	`87673890dc5c…`

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
63629-1027-1	METHADONE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1027-1	EA - Each	63629-1027	6f28868c-f31a-41a9-b06e-6c18e951bb47	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1027	METHADONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	10	Current NDC, Legacy NDC, 1 package rows	20230127_3ce98ab4-346b-4680-b3e1-a8c29b3933af.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	Ascend Laboratories, LLC	f0366917-f745-4b01-a662-a98a7d80b4a0	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090635 application number: ANDA090635
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	Bryant Ranch Prepack	7a8635fe-6183-4cda-9029-50e4e6dd5832	2023-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090635 application number: ANDA090635

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	3ce98ab4-346b-4680-b3e1-a8c29b3933af	10
864706	methadone hydrochloride 10 MG Oral Tablet	SCD	3ce98ab4-346b-4680-b3e1-a8c29b3933af	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1027-1	63629102701	100 TABLET in 1 BOTTLE (63629-1027-1)	100 tablet	2020-01-16	0000-00-00	No	No	Current