Acarbose

Product NDC: 0054-0141
11-digit product format: 000540141
Labeler code: 0054
Product ID: 0054-0141_2d7f6918-65c3-4db3-b775-b74e1e637cea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acarbose
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA078470
Marketing category: ANDA
Marketing start: 2008-05-07
Substance: ACARBOSE
Active strength: 50 mg/1
Pharmacologic classes: alpha Glucosidase Inhibitors [MoA], alpha-Glucosidase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0054-0141	0054-0141-20	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 · 11 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…`

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
A078470-001	ACARBOSE	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07
A078470-002	ACARBOSE	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07
A078470-003	ACARBOSE	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078470-001	AB
A078470-002	AB
A078470-003	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	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078470-002	ACARBOSE	50MG	TABLET / ORAL	AB	2008-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078470-003	ACARBOSE	100MG	TABLET / ORAL	AB	2008-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078470-001	ACARBOSE	25MG	TABLET / ORAL	AB	2008-05-07	`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	A078470-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078470-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078470-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078470-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078470-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078470-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078470-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078470-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078470-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078470-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078470-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078470-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078470-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078470-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078470-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078470-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078470-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078470-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078470-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078470-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078470-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078470-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078470-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078470-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078470-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078470-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078470-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078470-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078470-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078470-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078470-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078470-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078470-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078470-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078470-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078470-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078470-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078470-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078470-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078470-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acarbose
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACARBOSE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T58MSI464G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199149	Internal RxNorm lookup
199150	Internal RxNorm lookup
200132	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
352dd336-d3f9-4ac5-a000-91d3aef7aca3	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0054-0141-20	Acarbose	10 in 1 CARTON	TABLET	10	11
0054-0141-20	Acarbose	10 in 1 BLISTER PACK	TABLET	10	11
0054-0141-25	Acarbose	100 in 1 BOTTLE	TABLET	100	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0141-20	EA - Each	0054-0141	37687a7f-0296-4fe1-bc5f-85b9dd0e723a	1	2012-07-24
0054-0141-25	EA - Each	0054-0141	9374408e-4cb9-4a08-a15e-f8ab7e236749	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACARBOSE	ACTIVE INGREDIENT	T58MSI464G	ACARBOSE TABLET [ROXANE LABORATORIES, INC]	6
ACARBOSE	ACTIVE MOIETY	T58MSI464G	ACARBOSE TABLET [ROXANE LABORATORIES, INC]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACARBOSE TABLET [ROXANE LABORATORIES, INC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACARBOSE TABLET [ROXANE LABORATORIES, INC]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACARBOSE TABLET [ROXANE LABORATORIES, INC]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACARBOSE TABLET [ROXANE LABORATORIES, INC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0141	ACARBOSE TABLET [HIKMA PHARMACEUTICALS USA INC.]	11	Current NDC, Legacy NDC, 3 package rows	20240724_352dd336-d3f9-4ac5-a000-91d3aef7aca3.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
Acarbose	ACARBOSE	PD-Rx Pharmaceuticals, Inc.	722ce9eb-8f7b-4651-a287-d53dd7ab3707	2026-06-24	Adverse reactions	Exact identifier application applno (ANDA): 078470 application number: ANDA078470
Acarbose	ACARBOSE	Hikma Pharmaceuticals USA Inc.	352dd336-d3f9-4ac5-a000-91d3aef7aca3	2024-07-19	Adverse reactions	Exact identifier application applno (ANDA): 078470 application number: ANDA078470 ndc (product): 0054-0141

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
199150	acarbose 100 MG Oral Tablet	PSN	722ce9eb-8f7b-4651-a287-d53dd7ab3707	28
200132	acarbose 25 MG Oral Tablet	PSN	722ce9eb-8f7b-4651-a287-d53dd7ab3707	28
199149	acarbose 50 MG Oral Tablet	PSN	722ce9eb-8f7b-4651-a287-d53dd7ab3707	28
199150	acarbose 100 MG Oral Tablet	SCD	722ce9eb-8f7b-4651-a287-d53dd7ab3707	28
200132	acarbose 25 MG Oral Tablet	SCD	722ce9eb-8f7b-4651-a287-d53dd7ab3707	28
199149	acarbose 50 MG Oral Tablet	SCD	722ce9eb-8f7b-4651-a287-d53dd7ab3707	28
199150	acarbose 100 MG Oral Tablet	PSN	352dd336-d3f9-4ac5-a000-91d3aef7aca3	11
200132	acarbose 25 MG Oral Tablet	PSN	352dd336-d3f9-4ac5-a000-91d3aef7aca3	11
199149	acarbose 50 MG Oral Tablet	PSN	352dd336-d3f9-4ac5-a000-91d3aef7aca3	11
199150	acarbose 100 MG Oral Tablet	SCD	352dd336-d3f9-4ac5-a000-91d3aef7aca3	11
200132	acarbose 25 MG Oral Tablet	SCD	352dd336-d3f9-4ac5-a000-91d3aef7aca3	11
199149	acarbose 50 MG Oral Tablet	SCD	352dd336-d3f9-4ac5-a000-91d3aef7aca3	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0141-20	00054014120	10 BLISTER PACK in 1 CARTON (0054-0141-20) > 10 TABLET in 1 BLISTER PACK	10 blister pack	2008-05-07	0000-00-00	No	No	Current
0054-0141-25	00054014125	100 TABLET in 1 BOTTLE (0054-0141-25)	100 tablet	2008-05-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acarbose Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	29
Acarbose Tablets, USP	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2024-07-19	HUMAN PRESCRIPTION DRUG LABEL	11