Home NDC 0378-4150 Risedronate Sodium
Product NDC 0378-4150
11-digit product format 003784150
Labeler code 0378
Product ID 0378-4150_a55eb183-58db-4f47-8b9b-51e20449860c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risedronate sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA200477
Marketing category ANDA
Marketing start 2014-06-10
Marketing end 0000-00-00
Substance RISEDRONATE SODIUM
Active strength 150 mg/1
Pharmacologic classes Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200477-001 RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET / ORAL 2015-11-30 A200477-002 RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET / ORAL 2015-11-30 A200477-003 RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET / ORAL 2015-11-30 A200477-004 RISEDRONATE SODIUM RISEDRONATE SODIUM 75MG TABLET / ORAL 2014-06-10 A200477-005 RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG TABLET / ORAL 2014-06-10
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 6 · 210 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 A200477-001 RISEDRONATE SODIUM 5MG TABLET / ORAL 2015-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200477-002 RISEDRONATE SODIUM 30MG TABLET / ORAL 2015-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200477-003 RISEDRONATE SODIUM 35MG TABLET / ORAL 2015-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200477-004 RISEDRONATE SODIUM 75MG TABLET / ORAL 2014-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200477-005 RISEDRONATE SODIUM 150MG TABLET / ORAL 2014-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200477-001 RISEDRONATE SODIUM 5MG TABLET / ORAL 2015-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200477-002 RISEDRONATE SODIUM 30MG TABLET / ORAL 2015-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200477-003 RISEDRONATE SODIUM 35MG TABLET / ORAL 2015-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200477-004 RISEDRONATE SODIUM 75MG TABLET / ORAL 2014-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200477-005 RISEDRONATE SODIUM 150MG TABLET / ORAL 2014-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200477-001 RISEDRONATE SODIUM 5MG TABLET / ORAL 2015-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200477-002 RISEDRONATE SODIUM 30MG TABLET / ORAL 2015-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200477-003 RISEDRONATE SODIUM 35MG TABLET / ORAL 2015-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200477-004 RISEDRONATE SODIUM 75MG TABLET / ORAL 2014-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200477-005 RISEDRONATE SODIUM 150MG TABLET / ORAL 2014-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200477-001 RISEDRONATE SODIUM 5MG TABLET / ORAL 2015-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200477-002 RISEDRONATE SODIUM 30MG TABLET / ORAL 2015-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200477-003 RISEDRONATE SODIUM 35MG TABLET / ORAL 2015-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200477-004 RISEDRONATE SODIUM 75MG TABLET / ORAL 2014-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200477-005 RISEDRONATE SODIUM 150MG TABLET / ORAL 2014-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200477-001 RISEDRONATE SODIUM 5MG TABLET / ORAL 2015-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200477-002 RISEDRONATE SODIUM 30MG TABLET / ORAL 2015-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200477-003 RISEDRONATE SODIUM 35MG TABLET / ORAL 2015-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200477-004 RISEDRONATE SODIUM 75MG TABLET / ORAL 2014-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200477-005 RISEDRONATE SODIUM 150MG TABLET / ORAL 2014-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200477-001 RISEDRONATE SODIUM 5MG TABLET / ORAL 2015-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200477-002 RISEDRONATE SODIUM 30MG TABLET / ORAL 2015-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200477-003 RISEDRONATE SODIUM 35MG TABLET / ORAL 2015-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200477-004 RISEDRONATE SODIUM 75MG TABLET / ORAL 2014-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200477-005 RISEDRONATE SODIUM 150MG TABLET / ORAL 2014-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200477-001 RISEDRONATE SODIUM 5MG TABLET / ORAL 2015-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200477-002 RISEDRONATE SODIUM 30MG TABLET / ORAL 2015-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200477-003 RISEDRONATE SODIUM 35MG TABLET / ORAL 2015-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200477-004 RISEDRONATE SODIUM 75MG TABLET / ORAL 2014-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200477-005 RISEDRONATE SODIUM 150MG TABLET / ORAL 2014-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200477-001 RISEDRONATE SODIUM 5MG TABLET / ORAL 2015-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200477-002 RISEDRONATE SODIUM 30MG TABLET / ORAL 2015-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200477-003 RISEDRONATE SODIUM 35MG TABLET / ORAL 2015-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200477-004 RISEDRONATE SODIUM 75MG TABLET / ORAL 2014-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200477-005 RISEDRONATE SODIUM 150MG TABLET / ORAL 2014-06-10 2680178bc6a6…