Home NDC 68012-004 Glumetza
Product NDC 68012-004
11-digit product format 680120004
Labeler code 68012
Product ID 68012-004_41eb528d-e235-4563-833a-5cf36381d6db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metformin hydrochloride
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Santarus, Inc.
Application NDA021748
Marketing category NDA
Marketing start 2018-03-20
Substance METFORMIN HYDROCHLORIDE
Active strength 500 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021748-001 GLUMETZA METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE / ORAL RLD 2005-06-03 N021748-002 GLUMETZA METFORMIN HYDROCHLORIDE 1GM TABLET, EXTENDED RELEASE / ORAL RLD 2005-06-03
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 2026-08-01 22:54:32 2026-06 N021748-001 GLUMETZA 500MG TABLET, EXTENDED RELEASE / ORAL RLD 2005-06-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N021748-002 GLUMETZA 1GM TABLET, EXTENDED RELEASE / ORAL RLD 2005-06-03 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Glumetza
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METFORMIN HYDROCHLORIDE 500 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861015 Internal RxNorm lookup 861018 Internal RxNorm lookup 1807888 Internal RxNorm lookup 1807915 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68012-004-50 Glumetza 100 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 100 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded metformin hydrochloride ACTIVE INGREDIENT 786Z46389E GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6 metformin ACTIVE MOIETY 9100L32L2N GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6 crospovidone INACTIVE INGREDIENT 68401960MK GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6 glyceryl behenate INACTIVE INGREDIENT R8WTH25YS2 GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6 magnesium stearate INACTIVE INGREDIENT 70097M6I30 GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6 talc INACTIVE INGREDIENT 7SEV7J4R1U GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68012-004 GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.] 27 Current NDC, Legacy NDC, 1 package rows 20240328_fb832474-88d9-4e29-95cd-fbc446944cc4.zip
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 68012-004-50 68012000450 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-004-50) 2018-03-20 0000-00-00 No No Current