Methadone Hydrocloride

Product NDC: 17856-1928
11-digit product format: 178561928
Labeler code: 17856
Product ID: 17856-1928_8ff18c88-a1a0-4950-a4f5-3c35e889044c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methadone hydrochloride
Dosage form: CONCENTRATE
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA212093
Marketing category: ANDA
Marketing start: 2020-11-02
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: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-1928		I	Inactivated by FDA	2026-08-17
excluded package	package	17856-1928	17856-1928-4	I	Inactivated by FDA	2026-08-17
excluded package	package	17856-1928	17856-1928-5	I	Inactivated by FDA	2026-08-17
excluded package	package	17856-1928	17856-1928-6	I	Inactivated by FDA	2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-1928-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-1928-5	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-1928-4	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-1928-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-1928-5	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-1928-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-1928-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-1928-5	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-1928-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-1928-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-1928-5	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-1928-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-1928-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-1928-5	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-1928-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-1928-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-1928-5	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-1928-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-1928-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-1928-5	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-1928-4	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-1928-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-1928-5	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-1928-4	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-1928-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-1928-5	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-1928-4	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A212093-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA		2020-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212093-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212093-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212093-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212093-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212093-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212093-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212093-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212093-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212093-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212093-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212093-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212093-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212093-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212093-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212093-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212093-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212093-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212093-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212093-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212093-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212093-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212093-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212093-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212093-001	AA	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212093-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212093-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212093-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212093-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212093-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212093-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212093-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212093-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212093-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212093-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212093-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212093-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212093-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212093-001	AA	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49b	Product name	3	20250819
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
a48f0261-b6cc-12b3-49fd-ed131bc5aa96	Product name	4	20210902
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9	Product name	6	20200708
a6a96832-f31d-b458-45cb-abb8bd940b44	Product name	2	20200304
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-1928-4	2025-01-30	C162847	48780-1	2cef2736-6dd8-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE oral concentrate, USP, dye-free, sugar-free, unflavored, CII Initial U.S. Approval: 1947
17856-1928-5	2025-01-30	C162847	48780-1	2cef2736-6dd8-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE oral concentrate, USP, dye-free, sugar-free, unflavored, CII Initial U.S. Approval: 1947
17856-1928-6	2025-01-30	C162847	48780-1	2cef2736-6dd8-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL CONCENTRATE safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL CONCENTRATE. METHADONE HYDROCHLORIDE oral concentrate, USP, dye-free, sugar-free, unflavored, CII Initial U.S. Approval: 1947

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-1928-1	Methadone Hydrocloridedye-free, sugar-free, unflavored	60 in 1 BOX, UNIT-DOSE	CONCENTRATE	60	2
17856-1928-2	Methadone Hydrocloridedye-free, sugar-free, unflavored	60 in 1 BOX, UNIT-DOSE	CONCENTRATE	60	2
17856-1928-3	Methadone Hydrocloridedye-free, sugar-free, unflavored	60 in 1 BOX, UNIT-DOSE	CONCENTRATE	60	2
17856-1928-4	Methadone Hydrocloridedye-free, sugar-free, unflavored	5 in 1 SYRINGE	CONCENTRATE	5	2
17856-1928-5	Methadone Hydrocloridedye-free, sugar-free, unflavored	5 in 1 SYRINGE	CONCENTRATE	5	2
17856-1928-6	Methadone Hydrocloridedye-free, sugar-free, unflavored	5 in 1 SYRINGE	CONCENTRATE	5	2
17856-1928-7	Methadone Hydrocloridedye-free, sugar-free, unflavored	1 mL in 1 SYRINGE	CONCENTRATE	1	2
17856-1928-8	Methadone Hydrocloridedye-free, sugar-free, unflavored	0.5 mL in 1 SYRINGE	CONCENTRATE	0.5	2
17856-1928-9	Methadone Hydrocloridedye-free, sugar-free, unflavored	0.25 mL in 1 SYRINGE	CONCENTRATE	0.25	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-1928	METHADONE HYDROCLORIDE DYE-FREE, SUGAR-FREE, UNFLAVORED (METHADONE HYDROCHLORIDE) CONCENTRATE [ATLANTIC BIOLOGICALS CORP.]	2	Legacy NDC, 9 package rows	20230602_29079045-112f-4f60-992e-fb24116c0671.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Bryant Ranch Prepack	714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212093 application number: ANDA212093
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Bryant Ranch Prepack	f9dad5d5-3417-4992-99ee-6550f81add6b	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212093 application number: ANDA212093
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Lannett Company, Inc.	0955ea4a-c6b8-431f-ba42-9641b5b102ea	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212093 application number: ANDA212093
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Atlantic Biologicals Corp.	373c649e-798d-770e-e063-6294a90a6e47	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212093 application number: ANDA212093

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	29079045-112f-4f60-992e-fb24116c0671	2
991147	methadone hydrochloride 10 MG/ML Oral Solution	SCD	29079045-112f-4f60-992e-fb24116c0671	2
991147	methadone hydrochloride 10 MG per 1 ML Oral Solution	SY	29079045-112f-4f60-992e-fb24116c0671	2
991147	methadone hydrochloride 5 MG per 0.5 ML Oral Solution	SY	29079045-112f-4f60-992e-fb24116c0671	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-1928-1	17856192801	60 in 1 BOX, UNIT-DOSE						Historical
17856-1928-2	17856192802	60 in 1 BOX, UNIT-DOSE						Historical
17856-1928-3	17856192803	60 in 1 BOX, UNIT-DOSE						Historical
17856-1928-4	17856192804	5 BOX, UNIT-DOSE in 1 SYRINGE (17856-1928-4) > 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-1928-1) > 1 mL in 1 SYRINGE (17856-1928-7)		2022-09-09	0000-00-00	No	No	Current
17856-1928-5	17856192805	5 BOX, UNIT-DOSE in 1 SYRINGE (17856-1928-5) > 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-1928-2) > .5 mL in 1 SYRINGE (17856-1928-8)		2022-09-09	0000-00-00	No	No	Current
17856-1928-6	17856192806	5 BOX, UNIT-DOSE in 1 SYRINGE (17856-1928-6) > 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-1928-3) > .25 mL in 1 SYRINGE (17856-1928-9)		2022-09-09	0000-00-00	No	No	Current
17856-1928-7	17856192807	1 mL in 1 SYRINGE	1 ml					Historical
17856-1928-8	17856192808	0.5 mL in 1 SYRINGE	0.5 ml					Historical
17856-1928-9	17856192809	0.25 mL in 1 SYRINGE	0.25 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
methadone hydrochloride - ATLANTIC BIOLOGICALS CORP.	ATLANTIC BIOLOGICALS CORP.	2023-06-01	HUMAN PRESCRIPTION DRUG LABEL	2