METFORMIN HYDROCHLORIDE

Product NDC
43063-507
11-digit product format
430630507
Labeler code
43063
Product ID
43063-507_97cad7a2-7173-a1a7-e053-2a95a90ae6af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077064
Marketing category
ANDA
Marketing start
2005-09-28
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
850 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43063-507DDiscontinued by firm2026-10-05
excluded packagepackage43063-50743063-507-30DDiscontinued by firm2026-10-05
excluded packagepackage43063-50743063-507-60DDiscontinued by firm2026-10-05
excluded packagepackage43063-50743063-507-90DDiscontinued by firm2026-10-05
excluded packagepackage43063-50743063-507-93DDiscontinued by firm2026-10-05
excluded packagepackage43063-50743063-507-94DDiscontinued by firm2026-10-05
excluded packagepackage43063-50743063-507-98DDiscontinued by firm2026-10-05

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 2 · 84 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-507-93d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-507-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-507-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-507-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-507-94d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-507-98d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-507-93f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-507-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-507-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-507-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-507-94f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-507-98f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-507-932ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-507-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-507-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-507-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-507-942ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-507-982ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-507-93a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-507-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-507-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-507-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-507-94a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-507-98a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-507-93cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-507-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-507-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-507-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-507-94cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-507-98cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-507-93cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-507-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-507-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-507-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-507-94cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-507-98cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-507-93302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-507-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-507-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-507-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-507-94302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43063-507-98302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43063-507-93ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43063-507-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43063-507-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43063-507-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43063-507-94ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43063-507-98ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43063-507-930efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43063-507-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43063-507-300efc9e666f02…f202fb6c5f17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077064-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-18
A077064-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-18
A077064-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077064-001AB
A077064-002AB
A077064-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-1884e616aacf4f…
2026-09-14 22:38:342026-08A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-1884e616aacf4f…
2026-09-14 22:38:342026-08A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-1884e616aacf4f…
2026-08-18 06:07:402026-07A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077064-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2005-04-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077064-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2005-04-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077064-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2005-04-18301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077064-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077064-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077064-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077064-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077064-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077064-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077064-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077064-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077064-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077064-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077064-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077064-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077064-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077064-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077064-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077064-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077064-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077064-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077064-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077064-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077064-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077064-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077064-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077064-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077064-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077064-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077064-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077064-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077064-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077064-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077064-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077064-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077064-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077064-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077064-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077064-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077064-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077064-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077064-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077064-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-507-30EA - Each43063-507886d62ee-bbb5-4503-98fa-cfb43c235d3212014-05-02
43063-507-60EA - Each43063-5079c05d015-e35d-4312-8cec-5c09b293314f12014-05-02
43063-507-90EA - Each43063-50721ac3e63-2e0a-469e-b4a4-e5cc1603955c12014-05-02

DailyMed Socrata Ingredients#