Home NDC 43353-340 Metformin Hydrochloride
Product NDC 43353-340
11-digit product format 433530340
Labeler code 43353
Product ID 43353-340_f51ea50d-671d-4901-b5c0-e6135df7e54e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075985
Marketing category ANDA
Marketing start 2002-01-25
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 2019-12-31
Current FDA listing Historical FDA.report record
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 4 · 210 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A075985-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 A075985-002 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 A075985-003 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25
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 · 132 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 2026-10-15 13:18:30 2026-09 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075985-002 METFORMIN HYDROCHLORIDE 850MG TABLET / ORAL 2002-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075985-003 METFORMIN HYDROCHLORIDE 1GM TABLET / ORAL 2002-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075985-001 METFORMIN HYDROCHLORIDE 500MG TABLET / ORAL 2002-01-25 79d66fd596c7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 43353-340-30 Metformin Hydrochloride Tablets, USP 43353-340-53 Metformin Hydrochloride Tablets, USP 43353-340-60 Metformin Hydrochloride Tablets, USP 43353-340-70 Metformin Hydrochloride Tablets, USP 43353-340-75 Metformin Hydrochloride Tablets, USP 43353-340-80 Metformin Hydrochloride Tablets, USP 43353-340-92 Metformin Hydrochloride Tablets, USP 43353-340-94 Metformin Hydrochloride Tablets, USP 43353-340-96 Metformin Hydrochloride Tablets, USP
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-340-30 Metformin Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 43353-340-53 Metformin Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 2 43353-340-60 Metformin Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2 43353-340-70 Metformin Hydrochloride 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 2 43353-340-75 Metformin Hydrochloride 150 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 150 2 43353-340-80 Metformin Hydrochloride 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 2 43353-340-92 Metformin Hydrochloride 270 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 270 2 43353-340-94 Metformin Hydrochloride 360 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 360 2 43353-340-96 Metformin Hydrochloride 450 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 450 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 METFORMIN ACTIVE MOIETY 9100L32L2N METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-340 METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC, 9 package rows 20140626_f0eacf51-58ca-41d8-9f43-30b335fe1431.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-340-30 43353034030 30 in 1 BOTTLE, PLASTIC Historical 43353-340-53 43353034053 60 in 1 BOTTLE, PLASTIC Historical 43353-340-60 43353034060 90 in 1 BOTTLE, PLASTIC Historical 43353-340-70 43353034070 120 in 1 BOTTLE, PLASTIC Historical 43353-340-75 43353034075 150 in 1 BOTTLE, PLASTIC Historical 43353-340-80 43353034080 180 in 1 BOTTLE, PLASTIC Historical 43353-340-92 43353034092 270 in 1 BOTTLE, PLASTIC Historical 43353-340-94 43353034094 360 in 1 BOTTLE, PLASTIC Historical 43353-340-96 43353034096 450 in 1 BOTTLE, PLASTIC Historical