Home NDC 49483-620-01 Metformin HCl
Product NDC 49483-620
Requested package NDC 49483-620-01
11-digit product format 494830620
Labeler code 49483
Product ID 49483-620_2dc48b61-581f-fe5c-e063-6394a90aa557
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler TIME CAP LABORATORIES, INC
Application ANDA090888
Marketing category ANDA
Marketing start 2016-11-14
Substance METFORMIN HYDROCHLORIDE
Active strength 1000 mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49483-620 49483-620-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49483-620 49483-620-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49483-620 49483-620-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090888-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 A090888-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 A090888-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090888-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL AB 2012-03-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090888-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL AB 2012-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090888-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL AB 2012-03-12 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Metformin HCl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METFORMIN HYDROCHLORIDE 1000 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 786Z46389E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861004 Internal RxNorm lookup 861007 Internal RxNorm lookup 861010 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 49483-620-01 2025-02-10 These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 49483-620-10 2025-02-10 These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 49483-620-50 2025-02-10 These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 49483-620-81 2025-02-10 These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 49483-620-01 2025-01-30 These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 49483-620-10 2025-01-30 These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 49483-620-50 2025-01-30 These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995 49483-620-81 2025-01-30 These highlights do not include all the information needed to use Metformin Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Metformin Hydrochloride Tablets, USP. Metformin Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1995
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49483-620-01 Metformin HCl 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 6 49483-620-10 Metformin HCl 1000 in 1 PACKAGE TABLET, FILM COATED 1000 6 49483-620-50 Metformin HCl 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 6 49483-620-81 Metformin HCl 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-620 METFORMIN HCL TABLET, FILM COATED [TIME CAP LABORATORIES, INC] 6 Current NDC, Legacy NDC, 4 package rows 20250212_542cec22-eeae-4704-9bb6-4176640e5ea8.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49483-620-01 49483062001 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-620-01) 2016-11-16 0000-00-00 No No Current