Metformin Hydrochloride

Product NDC: 63187-239
11-digit product format: 631870239
Labeler code: 63187
Product ID: 63187-239_0564a4b6-70c2-4cf5-a0ec-c98e9e0eac61
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA077095
Marketing category: ANDA
Marketing start: 2005-01-14
Substance: METFORMIN HYDROCHLORIDE
Active strength: 1000 mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS]
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 42.

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
A077095-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14
A077095-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14
A077095-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077095-001	AB
A077095-002	AB
A077095-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2005-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2005-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077095-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2005-01-14	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077095-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077095-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077095-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077095-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077095-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077095-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077095-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077095-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077095-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077095-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077095-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077095-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077095-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077095-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077095-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077095-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077095-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077095-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077095-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077095-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077095-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077095-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METFORMIN HYDROCHLORIDE	1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
786Z46389E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861004	Internal RxNorm lookup
861007	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
1b9b6db9-1bac-4252-a03c-18dc0271f05f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63187-239-30	Metformin Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
63187-239-60	Metformin Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	4
63187-239-78	Metformin Hydrochloride	180 in 1 BOTTLE	TABLET, FILM COATED	180	4
63187-239-90	Metformin Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-239-30	EA - Each	63187-239	d0093f82-5961-4336-9f3f-4984c82d7090	1	2026-02-05
63187-239-78	EA - Each	63187-239	453b6293-61c5-4f1d-83bc-af4cf06417e5	1	2023-08-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1
METFORMIN	ACTIVE MOIETY	9100L32L2N	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-239	METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	4	Current NDC, Legacy NDC, 4 package rows	20230623_1b9b6db9-1bac-4252-a03c-18dc0271f05f.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5d8d654a-9bb4-4c87-ab43-c21c4e874708	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	583f2a2e-a9d7-f266-e063-6294a90ad0ab	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	4ac6d01a-af26-44e7-ae2e-3618de0080aa	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	fc466c46-abaa-4675-aef2-4b1a1adfd912	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	fb296500-55cb-45ce-be0c-59aa2e3d4624	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	073cf6d9-7142-4d8b-898e-174c62a1f76f	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	0448c618-2f0d-4ed3-866f-74b413cf902d	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1d7556eb-82b4-4085-b0b1-dc061b216feb	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	db113f46-6fac-9005-e053-2995a90a017a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3d450933-8d9d-27de-e063-6294a90ae6d9	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3ab4efb6-bd30-2583-e063-6294a90a415b	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	23aa50c5-28fe-4322-b5c6-1f1c48409b16	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	390c3bdf-bfaf-203e-e063-6394a90a7d20	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	23aa0072-365c-4d13-9aa7-ae23f7e00ee4	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1a7f7ef3-a94b-4ff6-a9f2-f5de4a99c7f6	2024-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	afb183f6-a13c-4f00-82d5-9fe336173d34	2024-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	1b9b6db9-1bac-4252-a03c-18dc0271f05f	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077095 application number: ANDA077095 ndc (product): 63187-239

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861004	metFORMIN HCl 1000 MG Oral Tablet	PSN	1b9b6db9-1bac-4252-a03c-18dc0271f05f	4
861007	metFORMIN HCl 500 MG Oral Tablet	PSN	1b9b6db9-1bac-4252-a03c-18dc0271f05f	4
861004	metformin hydrochloride 1000 MG Oral Tablet	SCD	1b9b6db9-1bac-4252-a03c-18dc0271f05f	4
861007	metformin hydrochloride 500 MG Oral Tablet	SCD	1b9b6db9-1bac-4252-a03c-18dc0271f05f	4
861004	metformin HCl 1 GM Oral Tablet	SY	1b9b6db9-1bac-4252-a03c-18dc0271f05f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-239-30	63187023930	30 TABLET, FILM COATED in 1 BOTTLE (63187-239-30)	2023-06-16		No	No	Current
63187-239-60	63187023960	60 TABLET, FILM COATED in 1 BOTTLE (63187-239-60)	2023-06-16		No	No	Current
63187-239-78	63187023978	180 TABLET, FILM COATED in 1 BOTTLE (63187-239-78)	2023-06-16		No	No	Current
63187-239-90	63187023990	90 TABLET, FILM COATED in 1 BOTTLE (63187-239-90)	2019-01-01	0000-00-00	No	No	Current