FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
50228-503
Requested package NDC
50228-503-60
11-digit product format
502280503
Labeler code
50228
Product ID
50228-503_dabc66fe-9cb1-3e39-e053-2995a90ab45f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride Extended-Release Tablets
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA214629
Marketing category
ANDA
Marketing start
2022-02-22
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214629-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-22
A214629-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214629-001AB2
A214629-002AB2

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 2 · 62 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-224b0b4de00fa7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-226a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-221c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214629-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB22022-02-22ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214629-002METFORMIN HYDROCHLORIDE1GMTABLET, EXTENDED RELEASE / ORALAB22022-02-22ea1830bbd6c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214629-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214629-002AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214629-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214629-002AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214629-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214629-002AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214629-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214629-002AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214629-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214629-002AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214629-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214629-002AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214629-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214629-002AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214629-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214629-002AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214629-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214629-002AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214629-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A214629-002AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214629-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214629-002AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214629-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214629-002AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214629-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214629-002AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214629-001AB218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214629-002AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214629-001AB215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214629-002AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214629-001AB215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214629-002AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214629-001AB214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214629-002AB214b0b4de00fa7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214629-001AB216a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214629-002AB216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214629-001AB211c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214629-002AB211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214629-001AB21ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214629-002AB21ea1830bbd6c7…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1807894Internal RxNorm lookup
1807917Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16dc4008-7b5e-4c6d-9bc8-8db96be911a1Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-503-05Metformin Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE5002
50228-503-30Metformin Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE302
50228-503-60Metformin Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-503-60EA - Each50228-503e1d54dee-4b26-4880-9e3f-acdb6527ca6412022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-503METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20220322_16dc4008-7b5e-4c6d-9bc8-8db96be911a1.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 HYDROCHLORIDE EXTENDED-RELEASE TABLETSScieGen Pharmaceuticals, Inc.16dc4008-7b5e-4c6d-9bc8-8db96be911a12022-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214629
application number: ANDA214629
ndc (package): 50228-503-60
ndc (product): 50228-503
ndc11 (package): 50228050360

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807894metFORMIN HCl 1000 MG Osmotic 24HR Extended Release Oral TabletPSN16dc4008-7b5e-4c6d-9bc8-8db96be911a12
1807917metFORMIN HCl 500 MG Osmotic 24HR Extended Release Oral TabletPSN16dc4008-7b5e-4c6d-9bc8-8db96be911a12
1807894Osmotic 24 HR metformin hydrochloride 1000 MG Extended Release Oral TabletSCD16dc4008-7b5e-4c6d-9bc8-8db96be911a12
1807917Osmotic 24 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD16dc4008-7b5e-4c6d-9bc8-8db96be911a12
1807894metformin HCl 1000 MG Osmotic 24 HR Extended Release Oral TabletSY16dc4008-7b5e-4c6d-9bc8-8db96be911a12
1807917metformin HCl 500 MG Osmotic 24HR Extended Release Oral TabletSY16dc4008-7b5e-4c6d-9bc8-8db96be911a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-503-605022805036060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-503-60) 2022-02-220000-00-00NoNoCurrent