Home NDC 33342-378 Metformin Hydrochloride
Product NDC 33342-378
11-digit product format 333420378
Labeler code 33342
Product ID 33342-378_727f5e27-e514-4014-93d5-c611dd0c790c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metformin Hydrochloride
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA211163
Marketing category ANDA
Marketing start 2024-03-13
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 43 .
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 A211163-001 METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL 2024-03-13
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 2026-09-14 22:38:34 2026-08 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL 2024-03-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL 2024-03-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL 2024-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL 2024-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL 2024-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL 2024-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL 2024-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL 2024-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB3 2024-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB3 2024-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB3 2024-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB3 2024-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB3 2024-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB3 2024-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB3 2024-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL AB3 2024-03-13 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211163-001 METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL 2024-03-13 a50c72e98297…
Observed Orange Book normalized TE history# 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 Ingredient Strength METFORMIN HYDROCHLORIDE 1000 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-378-10 Metformin Hydrochloride 90 in 1 BOTTLE TABLET, EXTENDED RELEASE 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-378 METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 1 package rows 20240331_2737f784-07ad-4e5a-862f-beaea31d005e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 33342-378-10 33342037810 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-378-10) 2024-03-13 No No Current