Home NDC 43547-395 Glimepiride
Product NDC 43547-395
11-digit product format 435470395
Labeler code 43547
Product ID 43547-395_95a5568d-751c-4497-b70c-5cc358bbb2af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glimepiride
Dosage form TABLET
Route ORAL
Labeler Solco Healthcare U.S., LLC
Application ANDA077370
Marketing category ANDA
Marketing start 2017-01-30
Substance GLIMEPIRIDE
Active strength 2 mg/1
Pharmacologic classes Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077370-001 GLIMEPIRIDE GLIMEPIRIDE 1MG TABLET / ORAL AB 2005-12-23 A077370-002 GLIMEPIRIDE GLIMEPIRIDE 2MG TABLET / ORAL AB 2005-12-23 A077370-003 GLIMEPIRIDE GLIMEPIRIDE 4MG TABLET / ORAL AB 2005-12-23 A077370-004 GLIMEPIRIDE GLIMEPIRIDE 8MG TABLET / ORAL AB 2005-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 168 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 2026-08-18 06:07:40 2026-07 A077370-001 GLIMEPIRIDE 1MG TABLET / ORAL AB 2005-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077370-002 GLIMEPIRIDE 2MG TABLET / ORAL AB 2005-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077370-003 GLIMEPIRIDE 4MG TABLET / ORAL AB 2005-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077370-004 GLIMEPIRIDE 8MG TABLET / ORAL AB 2005-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077370-001 GLIMEPIRIDE 1MG TABLET / ORAL AB 2005-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077370-002 GLIMEPIRIDE 2MG TABLET / ORAL AB 2005-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077370-003 GLIMEPIRIDE 4MG TABLET / ORAL AB 2005-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077370-004 GLIMEPIRIDE 8MG TABLET / ORAL AB 2005-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077370-001 GLIMEPIRIDE 1MG TABLET / ORAL AB 2005-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077370-002 GLIMEPIRIDE 2MG TABLET / ORAL AB 2005-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077370-003 GLIMEPIRIDE 4MG TABLET / ORAL AB 2005-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077370-004 GLIMEPIRIDE 8MG TABLET / ORAL AB 2005-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077370-001 GLIMEPIRIDE 1MG TABLET / ORAL AB 2005-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077370-002 GLIMEPIRIDE 2MG TABLET / ORAL AB 2005-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077370-003 GLIMEPIRIDE 4MG TABLET / ORAL AB 2005-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077370-004 GLIMEPIRIDE 8MG TABLET / ORAL AB 2005-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077370-001 GLIMEPIRIDE 1MG TABLET / ORAL AB 2005-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077370-002 GLIMEPIRIDE 2MG TABLET / ORAL AB 2005-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077370-003 GLIMEPIRIDE 4MG TABLET / ORAL AB 2005-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077370-004 GLIMEPIRIDE 8MG TABLET / ORAL AB 2005-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077370-001 GLIMEPIRIDE 1MG TABLET / ORAL AB 2005-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077370-002 GLIMEPIRIDE 2MG TABLET / ORAL AB 2005-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077370-003 GLIMEPIRIDE 4MG TABLET / ORAL AB 2005-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077370-004 GLIMEPIRIDE 8MG TABLET / ORAL AB 2005-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077370-001 GLIMEPIRIDE 1MG TABLET / ORAL AB 2005-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077370-002 GLIMEPIRIDE 2MG TABLET / ORAL AB 2005-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077370-003 GLIMEPIRIDE 4MG TABLET / ORAL AB 2005-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077370-004 GLIMEPIRIDE 8MG TABLET / ORAL AB 2005-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077370-001 GLIMEPIRIDE 1MG TABLET / ORAL AB 2005-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077370-002 GLIMEPIRIDE 2MG TABLET / ORAL AB 2005-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077370-003 GLIMEPIRIDE 4MG TABLET / ORAL AB 2005-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077370-004 GLIMEPIRIDE 8MG TABLET / ORAL AB 2005-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077370-001 GLIMEPIRIDE 1MG TABLET / ORAL AB 2005-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077370-002 GLIMEPIRIDE 2MG TABLET / ORAL AB 2005-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077370-003 GLIMEPIRIDE 4MG TABLET / ORAL AB 2005-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077370-004 GLIMEPIRIDE 8MG TABLET / ORAL AB 2005-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077370-001 GLIMEPIRIDE 1MG TABLET / ORAL AB 2005-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077370-002 GLIMEPIRIDE 2MG TABLET / ORAL AB 2005-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077370-003 GLIMEPIRIDE 4MG TABLET / ORAL AB 2005-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077370-004 GLIMEPIRIDE 8MG TABLET / ORAL AB 2005-12-23 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Glimepiride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLIMEPIRIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6KY687524K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199245 Internal RxNorm lookup 199246 Internal RxNorm lookup 199247 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 43547-395-10 Glimepiride 100 in 1 BOTTLE, PLASTIC TABLET 100 4 43547-395-50 Glimepiride 500 in 1 BOTTLE, PLASTIC TABLET 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-395 GLIMEPIRIDE TABLET [SOLCO HEALTHCARE U.S., LLC] 4 Current NDC, Legacy NDC, 2 package rows 20200824_86acdd9e-8637-43e4-8bf7-b3a123b871b8.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 43547-395-10 43547039510 100 TABLET in 1 BOTTLE, PLASTIC (43547-395-10) 100 tablet 2017-01-30 0000-00-00 No No Current 43547-395-50 43547039550 500 TABLET in 1 BOTTLE, PLASTIC (43547-395-50) 500 tablet 2017-01-30 0000-00-00 No No Current