Home NDC 64980-697-03 GLIPIZIDE
Product NDC 64980-697
Requested package NDC 64980-697-03
11-digit product format 649800697
Labeler code 64980
Product ID 64980-697_31a85319-fd49-49a6-a531-e7f456c774df
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glipizide
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA219159
Marketing category ANDA
Marketing start 2026-10-30
Substance GLIPIZIDE
Active strength 10 mg/1
Pharmacologic classes Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
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 45 .
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 A219159-001 GLIPIZIDE GLIPIZIDE 5MG TABLET / ORAL AB 2026-03-04 A219159-002 GLIPIZIDE GLIPIZIDE 10MG TABLET / ORAL AB 2026-03-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 2026-11-14 07:37:17 2026-10 A219159-001 GLIPIZIDE 5MG TABLET / ORAL AB 2026-03-04 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A219159-002 GLIPIZIDE 10MG TABLET / ORAL AB 2026-03-04 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A219159-001 GLIPIZIDE 5MG TABLET / ORAL AB 2026-03-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219159-002 GLIPIZIDE 10MG TABLET / ORAL AB 2026-03-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219159-001 GLIPIZIDE 5MG TABLET / ORAL AB 2026-03-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219159-002 GLIPIZIDE 10MG TABLET / ORAL AB 2026-03-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219159-001 GLIPIZIDE 5MG TABLET / ORAL AB 2026-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219159-002 GLIPIZIDE 10MG TABLET / ORAL AB 2026-03-04 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219159-001 GLIPIZIDE 5MG TABLET / ORAL AB 2026-03-04 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219159-002 GLIPIZIDE 10MG TABLET / ORAL AB 2026-03-04 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 GLIPIZIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLIPIZIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X7WDT95N5C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310488 Internal RxNorm lookup 310490 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64980-697-03 64980069703 30 TABLET in 1 BOTTLE (64980-697-03) 30 tablet 2026-10-30 No No Current