METFORMIN HYDROCHLORIDE

Product NDC
68382-029
11-digit product format
683820029
Labeler code
68382
Product ID
68382-029_4ca45053-c36e-40b6-a92a-b773bbbe830d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) 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
2019-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68382-029IInactivated by FDA2026-10-05
excluded productproduct68382-029DDiscontinued by firm2026-10-05
excluded packagepackage68382-02968382-029-61IInactivated by FDA2026-10-05
excluded packagepackage68382-02968382-029-01DDiscontinued by firm2026-10-05
excluded packagepackage68382-02968382-029-05DDiscontinued by firm2026-10-05
excluded packagepackage68382-02968382-029-10DDiscontinued by firm2026-10-05
excluded packagepackage68382-02968382-029-16DDiscontinued by firm2026-10-05
excluded packagepackage68382-02968382-029-77DDiscontinued 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 · 116 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-029-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-029-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-029-61IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-029-16DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-029-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-029-77DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-029-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-029-10DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-029-61IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-029-16DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-029-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-029-77DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-029-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-029-10DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-029-61IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-029-16DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-029-05DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68382-029-77DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-029-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-029-10DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-029-61IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-029-16DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-029-05DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68382-029-77DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-029-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-029-10DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-029-61IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-029-16DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-029-05DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68382-029-77DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-029-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-029-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-029-61IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-029-16DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-029-05DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68382-029-77DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-029-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-029-10DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-029-61IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-029-16DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-029-05DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68382-029-77DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-029-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68382-029-10DDiscontinued by firmed331223b511…672a5bd82f5f…

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68382-029-612019-10-29C16284748780-1960f7f55-d7ff-8e05-e053-dbdaa90a074aMetformin Hydrochloride Tablets, USP Metformin Hydrochloride Extended-release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-029-61METFORMIN HYDROCHLORIDE1000 in 1 BAGTABLET, FILM COATED10004
68382-029-61METFORMIN HYDROCHLORIDE10 in 1 DRUMTABLET, FILM COATED104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-029-01EA - Each68382-029be6ed051-5223-49cd-8b35-a15fe7f4237412012-07-24
68382-029-05EA - Each68382-02908960b2c-f22b-4d92-8b29-9bd12342213a12012-07-24
68382-029-10EA - Each68382-02941a6d309-8f40-49ee-a1f7-828266d1637e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]8
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]4
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]4
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]4
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-029METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]4Legacy NDC, 2 package rows20110517_ed03e4ec-311e-4a63-b7fa-cb4258b4b5fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSNed03e4ec-311e-4a63-b7fa-cb4258b4b5fb4
861007metFORMIN HCl 500 MG Oral TabletPSNed03e4ec-311e-4a63-b7fa-cb4258b4b5fb4
861010metFORMIN HCl 850 MG Oral TabletPSNed03e4ec-311e-4a63-b7fa-cb4258b4b5fb4
861004metformin hydrochloride 1000 MG Oral TabletSCDed03e4ec-311e-4a63-b7fa-cb4258b4b5fb4
861007metformin hydrochloride 500 MG Oral TabletSCDed03e4ec-311e-4a63-b7fa-cb4258b4b5fb4
861010metformin hydrochloride 850 MG Oral TabletSCDed03e4ec-311e-4a63-b7fa-cb4258b4b5fb4
861004metformin HCl 1 GM Oral TabletSYed03e4ec-311e-4a63-b7fa-cb4258b4b5fb4
861004metFORMIN HCl 1000 MG Oral TabletPSN29d05ca3-0ca0-4019-9b6c-6ecb86f903f62
861007metFORMIN HCl 500 MG Oral TabletPSN29d05ca3-0ca0-4019-9b6c-6ecb86f903f62
861010metFORMIN HCl 850 MG Oral TabletPSN29d05ca3-0ca0-4019-9b6c-6ecb86f903f62
861004metformin hydrochloride 1000 MG Oral TabletSCD29d05ca3-0ca0-4019-9b6c-6ecb86f903f62
861007metformin hydrochloride 500 MG Oral TabletSCD29d05ca3-0ca0-4019-9b6c-6ecb86f903f62
861010metformin hydrochloride 850 MG Oral TabletSCD29d05ca3-0ca0-4019-9b6c-6ecb86f903f62
861004metformin HCl 1 GM Oral TabletSY29d05ca3-0ca0-4019-9b6c-6ecb86f903f62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68382-029-61683820029611000 in 1 BAGHistorical