METHADOSE

Product NDC: 0406-8725
Requested package NDC: 0406-8725-15
11-digit product format: 004068725
Labeler code: 0406
Product ID: 0406-8725_eac074c9-ea47-4a82-a4c3-1149c30bf372
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methadone hydrochloride
Dosage form: CONCENTRATE
Route: ORAL
Labeler: SpecGx LLC
Application: NDA017116
Marketing category: NDA
Marketing start: 1973-03-14
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

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	0406-8725	0406-8725-15	D	Discontinued by firm		2026-08-11

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 · 12 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N017116-002	METHADOSE	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	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
N017116-002	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 · 41 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
2026-02-19 14:30 UTC	2026-02	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017116-002	METHADOSE	10MG/ML	CONCENTRATE / ORAL	AA	RLD, RS, Approved before 1982	`cb3db0bc1861…`

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	N017116-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017116-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017116-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017116-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017116-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017116-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017116-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017116-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017116-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017116-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017116-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017116-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017116-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017116-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017116-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017116-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017116-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017116-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017116-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017116-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017116-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017116-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017116-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017116-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017116-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017116-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017116-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017116-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017116-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017116-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017116-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017116-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017116-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017116-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017116-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017116-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017116-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017116-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017116-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017116-002	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: METHADOSE
Brand name suffix: SUGAR-FREE
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
991147	Internal RxNorm lookup
991149	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
808a9d0b-720b-4034-a862-5122ff514608	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
0406-8725-10	METHADOSESUGAR-FREE	1000 mL in 1 BOTTLE, PLASTIC	CONCENTRATE	1000		41
0406-8725-15	METHADOSESUGAR-FREE	15000 mL in 1 BOTTLE, PLASTIC	CONCENTRATE	15000		41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-8725-10	ML - Milliliter	0406-8725	80fb6dae-1e94-4769-9021-80fefc07fb9d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHADONE HYDROCHLORIDE	ACTIVE INGREDIENT	229809935B	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11
METHADONE	ACTIVE MOIETY	UC6VBE7V1Z	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11
SUCROSE	INACTIVE INGREDIENT	C151H8M554	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0406-8725	METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [SPECGX LLC]	39	Current NDC, Legacy NDC, 2 package rows	20241006_808a9d0b-720b-4034-a862-5122ff514608.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
METHADOSE	METHADONE HYDROCHLORIDE	SpecGx LLC	808a9d0b-720b-4034-a862-5122ff514608	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017116 application number: NDA017116 ndc (package): 0406-8725-15 ndc (product): 0406-8725 ndc11 (package): 00406872515

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	808a9d0b-720b-4034-a862-5122ff514608	41
991149	Methadose 10 MG in 1 mL Concentrate for Oral Solution	PSN	808a9d0b-720b-4034-a862-5122ff514608	41
991149	methadone hydrochloride 10 MG/ML Oral Solution [Methadose]	SBD	808a9d0b-720b-4034-a862-5122ff514608	41
991147	methadone hydrochloride 10 MG/ML Oral Solution	SCD	808a9d0b-720b-4034-a862-5122ff514608	41
991147	methadone hydrochloride 10 MG per 1 ML Oral Solution	SY	808a9d0b-720b-4034-a862-5122ff514608	41
991147	methadone hydrochloride 5 MG per 0.5 ML Oral Solution	SY	808a9d0b-720b-4034-a862-5122ff514608	41
991149	Methadose 10 MG per 1 ML Concentrate for Oral Solution	SY	808a9d0b-720b-4034-a862-5122ff514608	41

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0406-8725-15	00406872515	15000 mL in 1 BOTTLE, PLASTIC (0406-8725-15)	15000 ml	1973-03-14	0000-00-00	No	No	Current