Home NDC 66689-318 Metformin Hydrochloride
Product NDC 66689-318
11-digit product format 666890318
Labeler code 66689
Product ID 66689-318_88a5077b-b1b5-47bb-ab45-32de55907ea6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler VistaPharm, LLC
Application ANDA212677
Marketing category ANDA
Marketing start 2022-12-19
Substance METFORMIN HYDROCHLORIDE
Active strength 500 mg/5mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212677-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212677-001 AB
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.
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 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212677-001 METFORMIN HYDROCHLORIDE 500MG/5ML SOLUTION / ORAL AB 2022-08-19 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Metformin Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METFORMIN HYDROCHLORIDE 500 mg/5mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861025 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66689-318-16 Metformin Hydrochloride 1 in 1 CARTON SOLUTION 1 8 66689-318-16 Metformin Hydrochloride 473 mL in 1 BOTTLE SOLUTION 473 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66689-318 METFORMIN HYDROCHLORIDE SOLUTION [VISTAPHARM, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20241013_e087ce3b-8d7f-43a3-8d20-54513da7617d.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66689-318-16 66689031816 1 BOTTLE in 1 CARTON (66689-318-16) / 473 mL in 1 BOTTLE 1 bottle 2022-12-19 0000-00-00 No No Current