DISKETS

Product NDC: 0054-4538
11-digit product format: 000544538
Labeler code: 0054
Product ID: 0054-4538_5d09b929-38f0-4c89-8bf5-31427a5cd393
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methadone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA017058
Marketing category: NDA
Marketing start: 1973-03-14
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: 2027-12-31
Current FDA listing: Yes

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
N017058-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / 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
N017058-001	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	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017058-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	RLD, RS, Approved before 1982	`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	N017058-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017058-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017058-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017058-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017058-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017058-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017058-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017058-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017058-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017058-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017058-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017058-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017058-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017058-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017058-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017058-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017058-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017058-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017058-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017058-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017058-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017058-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017058-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017058-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017058-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017058-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017058-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017058-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017058-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017058-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017058-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017058-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017058-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017058-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017058-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017058-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017058-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017058-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017058-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017058-001	AA	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: DISKETS
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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
864978	Internal RxNorm lookup
1990745	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
e6af84de-cbfc-4a3b-bd73-6bcf77337168	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
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
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
0054-4538-25	DISKETS	100 in 1 BOTTLE, PLASTIC	TABLET	100		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-4538-25	EA - Each	0054-4538	fd70ce12-6fc2-4c2a-b167-db3d823bc958	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHADONE HYDROCHLORIDE	ACTIVE INGREDIENT	229809935B	DISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]	5
METHADONE	ACTIVE MOIETY	UC6VBE7V1Z	DISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]	5
POTASSIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	4J9FJ0HL51	DISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DISKETS (METHADONE HYDROCHLORIDE) TABLET [ROXANE LABORATORIES, INC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-4538	DISKETS (METHADONE HYDROCHLORIDE) TABLET [HIKMA PHARMACEUTICALS USA INC.]	15	Current NDC, Legacy NDC, 1 package rows	20240215_e6af84de-cbfc-4a3b-bd73-6bcf77337168.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
DISKETS	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	e6af84de-cbfc-4a3b-bd73-6bcf77337168	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017058 application number: NDA017058 ndc (product): 0054-4538

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
1990745	DISKETS 40 MG Tablet for Oral Suspension	PSN	e6af84de-cbfc-4a3b-bd73-6bcf77337168	19
864978	methadone HCl 40 MG Tablet for Oral Suspension	PSN	e6af84de-cbfc-4a3b-bd73-6bcf77337168	19
1990745	methadone hydrochloride 40 MG Tablet for Oral Suspension [Diskets]	SBD	e6af84de-cbfc-4a3b-bd73-6bcf77337168	19
864978	methadone hydrochloride 40 MG Tablet for Oral Suspension	SCD	e6af84de-cbfc-4a3b-bd73-6bcf77337168	19
1990745	Diskets 40 MG Tablet for Oral Suspension	SY	e6af84de-cbfc-4a3b-bd73-6bcf77337168	19
864978	methadone HCl 40 MG Tablet for Oral Suspension	SY	e6af84de-cbfc-4a3b-bd73-6bcf77337168	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-4538-25	00054453825	100 TABLET in 1 BOTTLE, PLASTIC (0054-4538-25)	100 tablet	1973-03-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DISKETS	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2025-12-01	HUMAN PRESCRIPTION DRUG LABEL	19