Methadone Hydrochloride

Product NDC: 17856-3553
11-digit product format: 178563553
Labeler code: 17856
Product ID: 17856-3553_37459ca8-3b45-473b-89bb-a6543da55493
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methadone Hydrochloride
Dosage form: CONCENTRATE
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA089897
Marketing category: ANDA
Marketing start: 2018-10-31
Marketing end: 0000-00-00
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: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-3553		I	Inactivated by FDA	2026-10-15
excluded package	package	17856-3553	17856-3553-1	I	Inactivated by FDA	2026-10-15
excluded package	package	17856-3553	17856-3553-2	I	Inactivated by FDA	2026-10-15

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 2 · 63 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-3553-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-3553-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-3553-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-3553-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-3553-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-3553-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-3553-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-3553-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-3553-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-3553-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-3553-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-3553-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-3553-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-3553-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-3553-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-3553-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-3553-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-3553-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-3553-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-3553-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-3553-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-3553-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-3553-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-3553-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-3553-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-3553-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-3553-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-3553-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-3553-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-3553-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	17856-3553-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	17856-3553-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	17856-3553-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	17856-3553-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	17856-3553-1	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	17856-3553-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	17856-3553-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	17856-3553-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	17856-3553-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	17856-3553-2	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A089897-001	METHADONE HYDROCHLORIDE INTENSOL	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA		1988-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089897-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089897-001	METHADONE HYDROCHLORIDE INTENSOL	10MG/ML	CONCENTRATE / ORAL	AA	1988-09-06	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A089897-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089897-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089897-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A089897-001	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-3553-1	2020-01-31	C162847	48780-1	9d75b9d0-bce0-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE INTENSOL TM (ORAL CONCENTRATE) safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE INTENSOL TM (ORAL CONCENTRATE) METHADONE HYDROCHLORIDE Intensol TM (oral concentrate), for oral use, CII Initial U.S. Approval: 1947
17856-3553-2	2020-01-31	C162847	48780-1	9d75b9d0-bce0-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE INTENSOL TM (ORAL CONCENTRATE) safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE INTENSOL TM (ORAL CONCENTRATE) METHADONE HYDROCHLORIDE Intensol TM (oral concentrate), for oral use, CII Initial U.S. Approval: 1947

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-3553-1	Methadone Hydrochloride	60 in 1 BOX, UNIT-DOSE	CONCENTRATE	60	1
17856-3553-1	Methadone Hydrochloride	1 mL in 1 SYRINGE	CONCENTRATE	1	1
17856-3553-2	Methadone Hydrochloride	0.5 mL in 1 SYRINGE	CONCENTRATE	0.5	1
17856-3553-2	Methadone Hydrochloride	60 in 1 BOX, UNIT-DOSE	CONCENTRATE	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-3553	METHADONE HYDROCHLORIDE CONCENTRATE [ATLANTIC BIOLOGICALS CORP.]	1	Legacy NDC, 4 package rows	20181101_52bea06c-6c93-4458-a79b-c3eb3a9166b6.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	Hikma Pharmaceuticals USA Inc.	d0e6a966-179a-45e0-8444-4c1b8523f8d2	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089897 application number: ANDA089897
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA	e72841bf-364b-49b1-8e69-7e26ddcd2657	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089897 application number: ANDA089897

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	52bea06c-6c93-4458-a79b-c3eb3a9166b6	1
991147	methadone hydrochloride 10 MG/ML Oral Solution	SCD	52bea06c-6c93-4458-a79b-c3eb3a9166b6	1
991147	methadone hydrochloride 10 MG per 1 ML Oral Solution	SY	52bea06c-6c93-4458-a79b-c3eb3a9166b6	1
991147	methadone hydrochloride 5 MG per 0.5 ML Oral Solution	SY	52bea06c-6c93-4458-a79b-c3eb3a9166b6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
17856-3553-1	17856355301	60 in 1 BOX, UNIT-DOSE		Historical
17856-3553-2	17856355302	0.5 mL in 1 SYRINGE	0.5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methadone Hydrochloride - ATLANTIC BIOLOGICALS CORP.	ATLANTIC BIOLOGICALS CORP.	2018-10-31	HUMAN PRESCRIPTION DRUG LABEL	1