Home NDC 0093-3098 Risedronate Sodium
Product NDC 0093-3098
11-digit product format 000933098
Labeler code 0093
Product ID 0093-3098_641c2a59-be2b-4246-8990-b7bf563012be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risedronate Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA077132
Marketing category ANDA
Marketing start 2015-06-01
Substance RISEDRONATE SODIUM MONOHYDRATE
Active strength 35 mg/1
Pharmacologic classes Bisphosphonate [EPC], Diphosphonates [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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077132-001 RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 A077132-002 RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 A077132-003 RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077132-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2007-10-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077132-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2007-10-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077132-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2007-10-05 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Risedronate Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RISEDRONATE SODIUM MONOHYDRATE 35 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F67L43UT5C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905024 Internal RxNorm lookup 905032 Internal RxNorm lookup 905041 Internal RxNorm lookup 905092 Internal RxNorm lookup 905100 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 0093-3098-19 Risedronate Sodium 1 in 1 BLISTER PACK TABLET, FILM COATED 1 15 0093-3098-29 Risedronate Sodium 12 in 1 CARTON TABLET, FILM COATED 12 15 0093-3098-44 Risedronate Sodium 4 in 1 CARTON TABLET, FILM COATED 4 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RISEDRONATE SODIUM MONOHYDRATE ACTIVE INGREDIENT F67L43UT5C RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 RISEDRONIC ACID ACTIVE MOIETY KM2Z91756Z RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-3098 RISEDRONATE SODIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 13 Current NDC, Legacy NDC, 3 package rows 20220330_dddcd321-4d2e-4643-bf3c-7b752b33ba39.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 0093-3098-19 00093309819 1 in 1 BLISTER PACK Historical 0093-3098-29 00093309829 12 BLISTER PACK in 1 CARTON (0093-3098-29) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) 12 blister pack 2015-06-01 0000-00-00 No No Current 0093-3098-44 00093309844 4 BLISTER PACK in 1 CARTON (0093-3098-44) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-3098-19) 4 blister pack 2015-06-01 0000-00-00 No No Current