FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
12634-756
Requested package NDC
12634-756-94
11-digit product format
126340756
Labeler code
12634
Product ID
12634-756_46625c1e-8ee1-4178-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA091184
Marketing category
ANDA
Marketing start
2011-01-31
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage12634-75612634-756-94IInactivated by FDA2026-08-10

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 1 · 16 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091184-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01
A091184-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01
A091184-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091184-001AB
A091184-002AB
A091184-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091184-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2010-11-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091184-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2010-11-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091184-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2010-11-018072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091184-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091184-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091184-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091184-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091184-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091184-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091184-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091184-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091184-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091184-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091184-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091184-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091184-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091184-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091184-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091184-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091184-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091184-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091184-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091184-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091184-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091184-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091184-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091184-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091184-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091184-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091184-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091184-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091184-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091184-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091184-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091184-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091184-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091184-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091184-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091184-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091184-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091184-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091184-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091184-001AB18072bd15b7f6…

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, Related label table
NDCRelated label
12634-756-40Metformin Hydrochloride Tablets USP
12634-756-52Metformin Hydrochloride Tablets USP
12634-756-54Metformin Hydrochloride Tablets USP
12634-756-66Metformin Hydrochloride Tablets USP
12634-756-69Metformin Hydrochloride Tablets USP
12634-756-74Metformin Hydrochloride Tablets USP
12634-756-78Metformin Hydrochloride Tablets USP
12634-756-91Metformin Hydrochloride Tablets USP
12634-756-96Metformin Hydrochloride Tablets USP
12634-756-97Metformin Hydrochloride Tablets USP
12634-756-98Metformin Hydrochloride Tablets USP
12634-756-99Metformin Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-756-00Metformin Hydrochloride10 in 1 BOTTLETABLET, FILM COATED102
12634-756-01Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
12634-756-09Metformin Hydrochloride35 in 1 BOTTLETABLET, FILM COATED352
12634-756-12Metformin Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1202
12634-756-18Metformin Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1802
12634-756-40Metformin Hydrochloride40 in 1 BOTTLETABLET, FILM COATED402
12634-756-42Metformin Hydrochloride42 in 1 BOTTLETABLET, FILM COATED422
12634-756-45Metformin Hydrochloride45 in 1 BOTTLETABLET, FILM COATED452
12634-756-50Metformin Hydrochloride50 in 1 BOTTLETABLET, FILM COATED502
12634-756-52Metformin Hydrochloride12 in 1 BLISTER PACKTABLET, FILM COATED122
12634-756-54Metformin Hydrochloride14 in 1 BLISTER PACKTABLET, FILM COATED142
12634-756-57Metformin Hydrochloride20 in 1 BLISTER PACKTABLET, FILM COATED202
12634-756-59Metformin Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED302
12634-756-60Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
12634-756-61Metformin Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
12634-756-63Metformin Hydrochloride3 in 1 BLISTER PACKTABLET, FILM COATED32
12634-756-66Metformin Hydrochloride6 in 1 BLISTER PACKTABLET, FILM COATED62
12634-756-67Metformin Hydrochloride7 in 1 BLISTER PACKTABLET, FILM COATED72
12634-756-69Metformin Hydrochloride9 in 1 BLISTER PACKTABLET, FILM COATED92
12634-756-71Metformin Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
12634-756-74Metformin Hydrochloride24 in 1 BOTTLETABLET, FILM COATED242
12634-756-78Metformin Hydrochloride28 in 1 BOTTLETABLET, FILM COATED282
12634-756-79Metformin Hydrochloride25 in 1 BOTTLETABLET, FILM COATED252
12634-756-80Metformin Hydrochloride20 in 1 BOTTLETABLET, FILM COATED202
12634-756-81Metformin Hydrochloride21 in 1 BOTTLETABLET, FILM COATED212
12634-756-82Metformin Hydrochloride12 in 1 BOTTLETABLET, FILM COATED122
12634-756-84Metformin Hydrochloride14 in 1 BOTTLETABLET, FILM COATED142
12634-756-85Metformin Hydrochloride15 in 1 BOTTLETABLET, FILM COATED152
12634-756-90Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902
12634-756-91Metformin Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
12634-756-92Metformin Hydrochloride2 in 1 BOTTLETABLET, FILM COATED22
12634-756-93Metformin Hydrochloride3 in 1 BOTTLETABLET, FILM COATED32
12634-756-94Metformin Hydrochloride4 in 1 BOTTLETABLET, FILM COATED42
12634-756-95Metformin Hydrochloride5 in 1 BOTTLETABLET, FILM COATED52
12634-756-96Metformin Hydrochloride6 in 1 BOTTLETABLET, FILM COATED62
12634-756-97Metformin Hydrochloride7 in 1 BOTTLETABLET, FILM COATED72
12634-756-98Metformin Hydrochloride8 in 1 BOTTLETABLET, FILM COATED82
12634-756-99Metformin Hydrochloride9 in 1 BOTTLETABLET, FILM COATED92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-756METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APOTHECA INC.]2Legacy NDC, 38 package rows20170118_4661d307-78b2-2f5b-e054-00144ff88e88.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAscend Laboratories, LLC0ff1ba75-3c86-4baf-a6b1-1bb8838398662025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091184
application number: ANDA091184

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN4661d307-78b2-2f5b-e054-00144ff88e882
861007metFORMIN HCl 500 MG Oral TabletPSN4661d307-78b2-2f5b-e054-00144ff88e882
861010metFORMIN HCl 850 MG Oral TabletPSN4661d307-78b2-2f5b-e054-00144ff88e882
861004metformin hydrochloride 1000 MG Oral TabletSCD4661d307-78b2-2f5b-e054-00144ff88e882
861007metformin hydrochloride 500 MG Oral TabletSCD4661d307-78b2-2f5b-e054-00144ff88e882
861010metformin hydrochloride 850 MG Oral TabletSCD4661d307-78b2-2f5b-e054-00144ff88e882
861004metformin HCl 1 GM Oral TabletSY4661d307-78b2-2f5b-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
12634-756-94126340756944 TABLET, FILM COATED in 1 BOTTLE (12634-756-94) 2011-01-310000-00-00NoNoCurrent