Betaine Anhydrous For Oral Solution

Product NDC: 55792-002
Requested package NDC: 55792-002-01
11-digit product format: 557920002
Labeler code: 55792
Product ID: 55792-002_30e4146a-b2bd-4dd3-9495-ff03c84b0c94
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: betaine
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Lukare Medical, LLC
Application: ANDA210508
Marketing category: ANDA
Marketing start: 2022-02-11
Marketing end: 0000-00-00
Substance: BETAINE
Active strength: 1 g/g
Pharmacologic classes: Methylating Activity [MoA], Methylating Agent [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55792-002	55792-002-01	I	Inactivated by FDA		2026-08-10

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A210508-001	BETAINE	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB		2022-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210508-001	AB

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
2026-02-19 14:30 UTC	2026-02	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210508-001	BETAINE	1GM/SCOOPFUL	FOR SOLUTION / ORAL	AB	2022-01-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210508-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210508-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210508-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210508-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210508-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210508-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210508-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210508-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210508-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210508-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210508-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210508-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210508-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210508-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210508-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210508-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210508-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210508-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210508-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210508-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210508-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210508-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210508-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210508-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210508-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210508-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210508-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210508-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210508-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210508-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210508-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210508-001	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55792-002-01	2024-01-30	C162847	48780-1	1030e365-29b5-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BETAINE ANHYDROUS FOR ORAL SOLUTION safely and effectively. See full prescribing information for BETAINE ANHYDROUS FOR ORAL SOLUTION. BETAINE ANHYDROUS FOR ORAL SOLUTION Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55792-002-01	Betaine Anhydrous For Oral Solution	180 g in 1 BOTTLE	POWDER, FOR SOLUTION	180		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55792-002-01	GM - Gram	55792-002	84fed15e-da64-4092-9f22-f9b7e571bb8c	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55792-002	BETAINE ANHYDROUS FOR ORAL SOLUTION (BETAINE) POWDER, FOR SOLUTION [LUKARE MEDICAL, LLC]	3	Legacy NDC, 1 package rows	20220212_ef44452a-5707-0d39-cbba-2fa285fb994c.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
Betaine Anhydrous	BETAINE ANHYDROUS	Eton Pharmaceuticals, Inc.	ee8a95c3-df9f-6e55-e053-2a95a90ab17b	2023-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210508 application number: ANDA210508

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3SCV180C9W	BETAINE	107-43-7	BETAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
562847	betaine anhydrous 1 GM/Scoop Powder for Oral Solution	PSN	ef44452a-5707-0d39-cbba-2fa285fb994c	3
562847	betaine 1000 MG Powder for Oral Solution	SCD	ef44452a-5707-0d39-cbba-2fa285fb994c	3
562847	betaine anhydrous 1 GM/Scoop Powder for Oral Solution	SY	ef44452a-5707-0d39-cbba-2fa285fb994c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55792-002-01	55792000201	180 g in 1 BOTTLE (55792-002-01)	180 g	2022-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Betaine Anhydrous For Oral Solution	Lukare Medical, LLC	2020-05-01	HUMAN PRESCRIPTION DRUG LABEL	3