Metformin Hydrochloride

Product NDC: 71335-1303
Requested package NDC: 71335-1303-2
11-digit product format: 713351303
Labeler code: 71335
Product ID: 71335-1303_490ede4f-2cc3-42ca-8d33-2d3f80348579
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA205096
Marketing category: ANDA
Marketing start: 2019-05-01
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Biguanide [EPC],Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	71335-1303	71335-1303-2	D	Discontinued by firm		2026-08-03

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
A205096-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11
A205096-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11
A205096-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205096-001	AB
A205096-002	AB
A205096-003	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	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`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	A205096-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205096-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205096-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205096-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205096-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205096-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205096-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205096-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205096-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205096-001	AB	1	`8072bd15b7f6…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1303	METFORMIN HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]	6	Legacy NDC	20241003_c2cc6c06-63bb-45f0-b318-78912abb392f.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4d4021ba-4b28-6b81-e063-6294a90a5ea7	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Precision Dose, Inc.	37ff1b8e-a434-41c0-82e1-4583842921a5	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Mullan Pharmaceutical Inc.	082b4de9-e452-fe71-e063-6394a90ac863	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	f6581ce6-0f9f-4887-ae83-4c6ecde619f3	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler, LLC	32ff33ed-89ed-c391-e063-6294a90ae414	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	565610b8-a9a0-4e5e-866d-81d9501a817d	2024-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	2d2ebf52-3d5e-4fad-b7f7-c9280957574c	2024-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	c2bbaa0c-5b05-4335-882f-14f1b443edd7	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	54ca16e6-1213-4877-8ace-477c764c8e76	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	583dac53-65e7-4710-912a-ecd89d07ad03	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1303-2	71335130302	60 TABLET, COATED in 1 BOTTLE (71335-1303-2)	2019-08-21	0000-00-00	No	No	Current