ACARBOSE

Product NDC: 69543-121
11-digit product format: 695430121
Labeler code: 69543
Product ID: 69543-121_2fe4e6ff-b000-436f-9a4c-530a190f081f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACARBOSE
Dosage form: TABLET
Route: ORAL
Labeler: Virtus Pharmaceuticals LLC
Application: ANDA091343
Marketing category: ANDA
Marketing start: 2015-02-01
Marketing end: 0000-00-00
Substance: ACARBOSE
Active strength: 50 mg/1
Pharmacologic classes: alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	69543-121		D	Discontinued by firm	2026-08-11
excluded package	package	69543-121	69543-121-10	D	Discontinued by firm	2026-08-11
excluded package	package	69543-121	69543-121-11	D	Discontinued by firm	2026-08-11

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 · 27 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	69543-121-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69543-121-10	`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	69543-121-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69543-121-10	`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	69543-121-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69543-121-10	`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	69543-121-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69543-121-10	`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	69543-121-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69543-121-10	`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	69543-121-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69543-121-10	`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	69543-121-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69543-121-10	`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	69543-121-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69543-121-10	`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	69543-121-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69543-121-10	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091343-001	ACARBOSE	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17
A091343-002	ACARBOSE	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17
A091343-003	ACARBOSE	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091343-001	AB
A091343-002	AB
A091343-003	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.

Product history page 1 of 4 · 123 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	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091343-002	ACARBOSE	50MG	TABLET / ORAL	AB	2013-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091343-003	ACARBOSE	100MG	TABLET / ORAL	AB	2013-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091343-001	ACARBOSE	25MG	TABLET / ORAL	AB	2013-10-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A091343-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091343-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091343-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091343-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091343-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091343-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091343-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091343-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091343-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091343-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091343-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091343-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091343-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091343-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091343-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091343-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091343-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091343-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091343-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091343-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091343-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091343-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091343-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091343-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091343-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091343-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091343-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091343-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091343-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091343-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091343-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091343-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091343-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091343-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091343-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091343-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091343-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091343-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091343-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091343-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2712f130-8721-1a9d-6846-53893b13fb67	Product name	2	20210312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69543-121-10	EA - Each	69543-121	c6deef3e-570a-4a03-84b3-08839c76e2d3	1	2015-07-20
69543-121-11	EA - Each	69543-121	bada7318-31d0-44db-a39f-cc1a6034ab85	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
acarbose	ACTIVE INGREDIENT	T58MSI464G	ACARBOSE (ACARBOSE) TABLET [AVKARE, INC.]	3
acarbose	ACTIVE MOIETY	T58MSI464G	ACARBOSE (ACARBOSE) TABLET [AVKARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACARBOSE (ACARBOSE) TABLET [AVKARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACARBOSE (ACARBOSE) TABLET [AVKARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACARBOSE (ACARBOSE) TABLET [AVKARE, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACARBOSE (ACARBOSE) TABLET [AVKARE, INC.]	3
acarbose	ACTIVE INGREDIENT	T58MSI464G	ACARBOSE TABLET [VIRTUS PHARMACEUTICALS LLC]	2
acarbose	ACTIVE MOIETY	T58MSI464G	ACARBOSE TABLET [VIRTUS PHARMACEUTICALS LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACARBOSE TABLET [VIRTUS PHARMACEUTICALS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACARBOSE TABLET [VIRTUS PHARMACEUTICALS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACARBOSE TABLET [VIRTUS PHARMACEUTICALS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACARBOSE TABLET [VIRTUS PHARMACEUTICALS LLC]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T58MSI464G	ACARBOSE	56180-94-0	ACARBOSE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199149	acarbose 50 MG Oral Tablet	PSN	c52016f3-98a0-455a-a1c8-0405b44208d7	1
199149	acarbose 50 MG Oral Tablet	SCD	c52016f3-98a0-455a-a1c8-0405b44208d7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69543-121-10	69543012110	100 TABLET in 1 BOTTLE (69543-121-10)	100 tablet	2015-02-01	0000-00-00	No	No	Current
69543-121-11	69543012111	1000 TABLET in 1 BOTTLE (69543-121-11)	1000 tablet	2015-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acarbose Tablets 25 mg, 50 mg and 100 mg Rx Only	Virtus Pharmaceuticals LLC	2024-12-09	HUMAN PRESCRIPTION DRUG LABEL	12
Acarbose Tablets 25 mg, 50 mg and 100 mg Rx Only	Proficient Rx LP	2024-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Acarbose Tablets 25 mg, 50 mg and 100 mg Rx Only	AvKARE	2024-01-03	HUMAN PRESCRIPTION DRUG LABEL	9
Acarbose Tablets 25 mg, 50 mg and 100 mg Rx Only	Bryant Ranch Prepack	2020-09-23	HUMAN PRESCRIPTION DRUG LABEL	1