METHADOSE DISPERSIBLE

Product NDC: 0406-0540
11-digit product format: 004060540
Labeler code: 0406
Product ID: 0406-0540_991d6748-896f-42c1-88d6-fe1e77275181
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methadone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: SpecGx LLC
Application: ANDA074184
Marketing category: ANDA
Marketing start: 1993-04-29
Substance: METHADONE HYDROCHLORIDE
Active strength: 40 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074184-001	METHADOSE	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA		1993-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074184-001	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 · 41 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	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074184-001	METHADOSE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1993-04-29	`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	A074184-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074184-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074184-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074184-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074184-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074184-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074184-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074184-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074184-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074184-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074184-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074184-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074184-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074184-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074184-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074184-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074184-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074184-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074184-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074184-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074184-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074184-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074184-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074184-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074184-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074184-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074184-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074184-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074184-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074184-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074184-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074184-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074184-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074184-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074184-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074184-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074184-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074184-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074184-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074184-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: METHADOSE DISPERSIBLE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHADONE HYDROCHLORIDE	40 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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
544483e6-6f9d-4371-9e93-313e54e0ea05	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
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
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
0406-0540-34	METHADOSE DISPERSIBLE	100 in 1 BOTTLE	TABLET	100		35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-0540-34	EA - Each	0406-0540	e2c7ddbe-6153-462d-a073-d9ce2b335364	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHADONE HYDROCHLORIDE	ACTIVE INGREDIENT	229809935B	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]	15
METHADONE	ACTIVE MOIETY	UC6VBE7V1Z	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]	15
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]	15
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]	15
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]	15
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]	15
POTASSIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	4J9FJ0HL51	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]	15
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0406-0540	METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [SPECGX LLC]	35	Current NDC, Legacy NDC, 1 package rows	20240724_544483e6-6f9d-4371-9e93-313e54e0ea05.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 DISPERSIBLE	METHADONE HYDROCHLORIDE	SpecGx LLC	544483e6-6f9d-4371-9e93-313e54e0ea05	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074184 application number: ANDA074184 ndc (product): 0406-0540

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
864978	methadone HCl 40 MG Tablet for Oral Suspension	PSN	544483e6-6f9d-4371-9e93-313e54e0ea05	35
864980	METHADOSE 40 MG Tablet for Oral Suspension	PSN	544483e6-6f9d-4371-9e93-313e54e0ea05	35
864980	methadone hydrochloride 40 MG Tablet for Oral Suspension [Methadose]	SBD	544483e6-6f9d-4371-9e93-313e54e0ea05	35
864978	methadone hydrochloride 40 MG Tablet for Oral Suspension	SCD	544483e6-6f9d-4371-9e93-313e54e0ea05	35
864978	methadone HCl 40 MG Tablet for Oral Suspension	SY	544483e6-6f9d-4371-9e93-313e54e0ea05	35
864980	Methadose 40 MG Tablet for Oral Suspension	SY	544483e6-6f9d-4371-9e93-313e54e0ea05	35

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0406-0540-34	00406054034	100 TABLET in 1 BOTTLE (0406-0540-34)	100 tablet	1993-04-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METHADOSE DISPERSIBLE	SpecGx LLC	2026-08-04	HUMAN PRESCRIPTION DRUG LABEL	36
METHADOSE DISPERSIBLE	American Health Packaging	2018-08-13	HUMAN PRESCRIPTION DRUG LABEL	3