FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
50228-107
11-digit product format
502280107
Labeler code
50228
Product ID
50228-107_10bdcce2-08e7-4d4d-b655-33c57ccafadc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA203769
Marketing category
ANDA
Marketing start
2015-02-01
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203769-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11
A203769-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-11
A203769-003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-11
A203769-004METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE625MGTABLET / ORALAB2026-02-09
A203769-005METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE750MGTABLET / ORALAB2026-02-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A203769-001AB
A203769-002AB
A203769-003AB
A203769-004AB
A203769-005AB

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 · 142 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11c2088c7a36db…
2026-10-15 13:18:302026-09A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-11c2088c7a36db…
2026-10-15 13:18:302026-09A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-11c2088c7a36db…
2026-10-15 13:18:302026-09A203769-004METFORMIN HYDROCHLORIDE625MGTABLET / ORALAB2026-02-09c2088c7a36db…
2026-10-15 13:18:302026-09A203769-005METFORMIN HYDROCHLORIDE750MGTABLET / ORALAB2026-02-09c2088c7a36db…
2026-09-14 22:38:342026-08A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A203769-004METFORMIN HYDROCHLORIDE625MGTABLET / ORALAB2026-02-0984e616aacf4f…
2026-09-14 22:38:342026-08A203769-005METFORMIN HYDROCHLORIDE750MGTABLET / ORALAB2026-02-0984e616aacf4f…
2026-08-18 06:07:402026-07A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-004METFORMIN HYDROCHLORIDE625MGTABLET / ORALAB2026-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-005METFORMIN HYDROCHLORIDE750MGTABLET / ORALAB2026-02-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-004METFORMIN HYDROCHLORIDE625MGTABLET / ORALAB2026-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-005METFORMIN HYDROCHLORIDE750MGTABLET / ORALAB2026-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203769-003METFORMIN HYDROCHLORIDE1GMTABLET / ORALAB2013-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203769-001METFORMIN HYDROCHLORIDE500MGTABLET / ORALAB2013-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203769-002METFORMIN HYDROCHLORIDE850MGTABLET / ORALAB2013-09-115bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 142 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A203769-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A203769-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A203769-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A203769-004AB1c2088c7a36db…
2026-10-15 13:18:302026-09A203769-005AB1c2088c7a36db…
2026-09-14 22:38:342026-08A203769-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203769-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203769-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A203769-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A203769-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A203769-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203769-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203769-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203769-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203769-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203769-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203769-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203769-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203769-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203769-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203769-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203769-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203769-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203769-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203769-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203769-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203769-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203769-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203769-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203769-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203769-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203769-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203769-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203769-002AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
METFORMIN HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
786Z46389EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861004Internal RxNorm lookup
861007Internal RxNorm lookup
861010Internal RxNorm lookup
861021Internal RxNorm lookup
2703582Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e4c4ba9-65c6-4273-8f6b-2423ab521dadAvailable on FDA.report

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-107-00METFORMIN HYDROCHLORIDE100 in 1 BOTTLETABLET1009
50228-107-01METFORMIN HYDROCHLORIDE100 in 1 BOTTLETABLET1009
50228-107-05METFORMIN HYDROCHLORIDE500 in 1 BOTTLETABLET5009
50228-107-10METFORMIN HYDROCHLORIDE1000 in 1 BOTTLETABLET10009
50228-107-30METFORMIN HYDROCHLORIDE30 in 1 BOTTLETABLET309
50228-107-60METFORMIN HYDROCHLORIDE60 in 1 BOTTLETABLET609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-107-01EA - Each50228-107ba60cf26-16a9-48fd-9042-bd2b8958715412019-05-02
50228-107-05EA - Each50228-10775760be2-2932-49cc-92aa-3c4e3d16aafa12019-03-12
50228-107-10EA - Each50228-1079ec2a30d-0d13-4343-84ad-638e5f39929512019-08-06
50228-107-30EA - Each50228-10733f06a36-fd1f-426c-a339-cf8c73f0041412019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
ACACIAINACTIVE INGREDIENT5C5403N26OMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6METFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETFORMIN HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]3
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-107METFORMIN HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS INC]9Current NDC, Legacy NDC, 6 package rows20230110_4e4c4ba9-65c6-4273-8f6b-2423ab521dad.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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.f86bda10-8b25-4125-8bb1-1b5917969ff02023-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack76879512-3ab4-4acf-92e6-bba0fb75dd0e2023-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepacka59327bd-a3ba-417b-9e91-4cd3a941e6402023-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepacka79d2674-071f-4641-9b11-406e02c5530a2023-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd0bee456-c8cd-46a1-acb3-5313a8cddd302022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP738402d6-3700-46b2-a90c-2e8f2c354a392022-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch Prepack9632456f-57c2-444b-9f43-d9ca862681fe2021-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEACI Healthcare USA, Inc.e18b60f9-721e-4db6-9f61-d3437e18faf22020-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203769
application number: ANDA203769

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN4670d280-53c3-4c51-b3c5-26d71e47bddc104
861004metformin hydrochloride 1000 MG Oral TabletSCD4670d280-53c3-4c51-b3c5-26d71e47bddc104
861004metformin HCl 1 GM Oral TabletSY4670d280-53c3-4c51-b3c5-26d71e47bddc104
861004metFORMIN HCl 1000 MG Oral TabletPSNa79d2674-071f-4641-9b11-406e02c5530a102
861004metFORMIN HCl 1000 MG Oral TabletPSN8ce6b615-2abd-4a5b-997b-11aa1aec142d102
861004metformin hydrochloride 1000 MG Oral TabletSCDa79d2674-071f-4641-9b11-406e02c5530a102
861004metformin hydrochloride 1000 MG Oral TabletSCD8ce6b615-2abd-4a5b-997b-11aa1aec142d102
861004metformin HCl 1 GM Oral TabletSYa79d2674-071f-4641-9b11-406e02c5530a102
861004metformin HCl 1 GM Oral TabletSY8ce6b615-2abd-4a5b-997b-11aa1aec142d102
861004metFORMIN HCl 1000 MG Oral TabletPSN9c33414b-5dbb-4ce9-910b-9480d45e50ee100
861004metformin hydrochloride 1000 MG Oral TabletSCD9c33414b-5dbb-4ce9-910b-9480d45e50ee100
861004metformin HCl 1 GM Oral TabletSY9c33414b-5dbb-4ce9-910b-9480d45e50ee100
861004metFORMIN HCl 1000 MG Oral TabletPSNf86bda10-8b25-4125-8bb1-1b5917969ff013
861004metFORMIN HCl 1000 MG Oral TabletPSNc33e24e9-0441-6b94-e053-2a95a90a9c6813
861007metFORMIN HCl 500 MG Oral TabletPSNf86bda10-8b25-4125-8bb1-1b5917969ff013
861007metFORMIN HCl 500 MG Oral TabletPSNc33e24e9-0441-6b94-e053-2a95a90a9c6813
861010metFORMIN HCl 850 MG Oral TabletPSNf86bda10-8b25-4125-8bb1-1b5917969ff013
861010metFORMIN HCl 850 MG Oral TabletPSNc33e24e9-0441-6b94-e053-2a95a90a9c6813
861004metformin hydrochloride 1000 MG Oral TabletSCDc33e24e9-0441-6b94-e053-2a95a90a9c6813
861004metformin hydrochloride 1000 MG Oral TabletSCDf86bda10-8b25-4125-8bb1-1b5917969ff013
861007metformin hydrochloride 500 MG Oral TabletSCDf86bda10-8b25-4125-8bb1-1b5917969ff013
861007metformin hydrochloride 500 MG Oral TabletSCDc33e24e9-0441-6b94-e053-2a95a90a9c6813
861010metformin hydrochloride 850 MG Oral TabletSCDc33e24e9-0441-6b94-e053-2a95a90a9c6813
861010metformin hydrochloride 850 MG Oral TabletSCDf86bda10-8b25-4125-8bb1-1b5917969ff013
861004metformin HCl 1 GM Oral TabletSYf86bda10-8b25-4125-8bb1-1b5917969ff013
861004metformin HCl 1 GM Oral TabletSYc33e24e9-0441-6b94-e053-2a95a90a9c6813
861004metFORMIN HCl 1000 MG Oral TabletPSN4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861007metFORMIN HCl 500 MG Oral TabletPSN4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861010metFORMIN HCl 850 MG Oral TabletPSN4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861004metformin hydrochloride 1000 MG Oral TabletSCD4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861007metformin hydrochloride 500 MG Oral TabletSCD4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861010metformin hydrochloride 850 MG Oral TabletSCD4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861004metformin HCl 1 GM Oral TabletSY4e4c4ba9-65c6-4273-8f6b-2423ab521dad9
861004metFORMIN HCl 1000 MG Oral TabletPSNec3a9070-3745-41fb-b610-8d06129d8fd92
861004metformin hydrochloride 1000 MG Oral TabletSCDec3a9070-3745-41fb-b610-8d06129d8fd92
861004metformin HCl 1 GM Oral TabletSYec3a9070-3745-41fb-b610-8d06129d8fd92
861004metFORMIN HCl 1000 MG Oral TabletPSNc224d5a3-70e4-5188-e053-2995a90ab2611
861004metFORMIN HCl 1000 MG Oral TabletPSNd0bee456-c8cd-46a1-acb3-5313a8cddd301
861004metFORMIN HCl 1000 MG Oral TabletPSN51e1fe6e-a7fa-47a5-bbd5-73b275230c7f1
861004metFORMIN HCl 1000 MG Oral TabletPSN72dbc087-9a84-4126-bf54-c5254a8b129c1
861004metFORMIN HCl 1000 MG Oral TabletPSNc0096dcc-b100-9baf-e053-2995a90a71561
861004metformin hydrochloride 1000 MG Oral TabletSCD72dbc087-9a84-4126-bf54-c5254a8b129c1
861004metformin hydrochloride 1000 MG Oral TabletSCDd0bee456-c8cd-46a1-acb3-5313a8cddd301
861004metformin hydrochloride 1000 MG Oral TabletSCD51e1fe6e-a7fa-47a5-bbd5-73b275230c7f1
861004metformin hydrochloride 1000 MG Oral TabletSCDc224d5a3-70e4-5188-e053-2995a90ab2611
861004metformin hydrochloride 1000 MG Oral TabletSCDc0096dcc-b100-9baf-e053-2995a90a71561
861004metformin HCl 1 GM Oral TabletSYc0096dcc-b100-9baf-e053-2995a90a71561
861004metformin HCl 1 GM Oral TabletSYd0bee456-c8cd-46a1-acb3-5313a8cddd301
861004metformin HCl 1 GM Oral TabletSY51e1fe6e-a7fa-47a5-bbd5-73b275230c7f1
861004metformin HCl 1 GM Oral TabletSY72dbc087-9a84-4126-bf54-c5254a8b129c1
861004metformin HCl 1 GM Oral TabletSYc224d5a3-70e4-5188-e053-2995a90ab2611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-107-0050228010700100 TABLET in 1 BOTTLE (50228-107-00) 100 tablet2015-02-010000-00-00NoNoCurrent
50228-107-0150228010701100 TABLET in 1 BOTTLE (50228-107-01) 100 tablet2015-02-010000-00-00NoNoCurrent
50228-107-0550228010705500 TABLET in 1 BOTTLE (50228-107-05) 500 tablet2015-02-010000-00-00NoNoCurrent
50228-107-10502280107101000 TABLET in 1 BOTTLE (50228-107-10) 1000 tablet2015-02-010000-00-00NoNoCurrent
50228-107-305022801073030 TABLET in 1 BOTTLE (50228-107-30) 30 tablet2015-02-010000-00-00NoNoCurrent
50228-107-605022801076060 TABLET in 1 BOTTLE (50228-107-60) 60 tablet2022-12-260000-00-00NoNoCurrent