Acarbose

Product NDC: 62135-455
Requested package NDC: 62135-455-90
11-digit product format: 621350455
Labeler code: 62135
Product ID: 62135-455_458bb3c6-f92c-cf49-e063-6294a90a96c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acarbose
Dosage form: TABLET
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA202271
Marketing category: ANDA
Marketing start: 2021-04-16
Substance: ACARBOSE
Active strength: 100 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A202271-001	ACARBOSE	ACARBOSE	25MG	TABLET / ORAL	2012-02-07
A202271-002	ACARBOSE	ACARBOSE	50MG	TABLET / ORAL	2012-02-07
A202271-003	ACARBOSE	ACARBOSE	100MG	TABLET / ORAL	2012-02-07

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 · 129 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
2026-09-14 22:38:34	2026-08	A202271-001	ACARBOSE	25MG	TABLET / ORAL		2012-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202271-002	ACARBOSE	50MG	TABLET / ORAL		2012-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202271-003	ACARBOSE	100MG	TABLET / ORAL		2012-02-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202271-001	ACARBOSE	25MG	TABLET / ORAL		2012-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202271-002	ACARBOSE	50MG	TABLET / ORAL		2012-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202271-003	ACARBOSE	100MG	TABLET / ORAL		2012-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202271-002	ACARBOSE	50MG	TABLET / ORAL	AB	2012-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202271-003	ACARBOSE	100MG	TABLET / ORAL	AB	2012-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202271-001	ACARBOSE	25MG	TABLET / ORAL	AB	2012-02-07	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A202271-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202271-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202271-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202271-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202271-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202271-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202271-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202271-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202271-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202271-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202271-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202271-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202271-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202271-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202271-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202271-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202271-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202271-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202271-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202271-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202271-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202271-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202271-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202271-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202271-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202271-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202271-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202271-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202271-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202271-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202271-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202271-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202271-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202271-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202271-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202271-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202271-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202271-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202271-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202271-001	AB	1	`8072bd15b7f6…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACARBOSE	100 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
d1b627e1-d78d-47dd-93f5-2bf4998466ba	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	Strength	SPL version
62135-455-90	Acarbose	90 in 1 BOTTLE	TABLET	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-455-90	EA - Each	62135-455	8f5ab3f5-e56a-4776-a19e-8d35593ad9f0	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-455	ACARBOSE TABLET [CHARTWELL RX, LLC]	2	Current NDC, 1 package rows	20241012_d1b627e1-d78d-47dd-93f5-2bf4998466ba.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acarbose	ACARBOSE	Bryant Ranch Prepack	067c0adc-7322-489d-9baa-1d061b37be36	2026-07-16	Adverse reactions	Exact identifier application applno (ANDA): 202271 application number: ANDA202271
Acarbose	ACARBOSE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	29939129-7d09-4c22-bf3e-491a8a97f4c4	2026-06-18	Adverse reactions	Exact identifier application applno (ANDA): 202271 application number: ANDA202271
Acarbose	ACARBOSE	Chartwell RX, LLC	d1b627e1-d78d-47dd-93f5-2bf4998466ba	2025-12-09	Adverse reactions	Exact identifier application applno (ANDA): 202271 application number: ANDA202271 ndc (package): 62135-455-90 ndc (product): 62135-455 ndc11 (package): 62135045590

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	d1b627e1-d78d-47dd-93f5-2bf4998466ba	3
200132	acarbose 25 MG Oral Tablet	PSN	d1b627e1-d78d-47dd-93f5-2bf4998466ba	3
199149	acarbose 50 MG Oral Tablet	PSN	d1b627e1-d78d-47dd-93f5-2bf4998466ba	3
199150	acarbose 100 MG Oral Tablet	SCD	d1b627e1-d78d-47dd-93f5-2bf4998466ba	3
200132	acarbose 25 MG Oral Tablet	SCD	d1b627e1-d78d-47dd-93f5-2bf4998466ba	3
199149	acarbose 50 MG Oral Tablet	SCD	d1b627e1-d78d-47dd-93f5-2bf4998466ba	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-455-90	62135045590	90 TABLET in 1 BOTTLE (62135-455-90)	90 tablet	2023-01-31	No	No	Current