Home NDC 67457-446 Pamidronate Disodium
Product NDC 67457-446
11-digit product format 674570446
Labeler code 67457
Product ID 67457-446_e3a78042-50cb-49d9-a31e-51d8edddbf4c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pamidronate Disodium
Dosage form INJECTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA078520
Marketing category ANDA
Marketing start 2011-05-10
Substance PAMIDRONATE DISODIUM
Active strength 9 mg/mL
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 43 .
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 A078520-001 PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 A078520-002 PAMIDRONATE DISODIUM PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31
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.
Product history page 1 of 3 · 86 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 2026-09-14 22:38:34 2026-08 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP2 2008-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP 2008-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP 2008-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP 2008-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP 2008-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP 2008-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP 2008-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078520-001 PAMIDRONATE DISODIUM 30MG/10ML (3MG/ML) INJECTABLE / INJECTION AP 2008-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078520-002 PAMIDRONATE DISODIUM 90MG/10ML (9MG/ML) INJECTABLE / INJECTION AP 2008-10-31 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pamidronate Disodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAMIDRONATE DISODIUM 9 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8742T8ZQZA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1737449 Internal RxNorm lookup 1737453 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 67457-446-10 Pamidronate Disodium 10 mL in 1 VIAL INJECTION 10 5 67457-446-10 Pamidronate Disodium 1 in 1 CARTON INJECTION 1 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-446 PAMIDRONATE DISODIUM INJECTION [MYLAN INSTITUTIONAL LLC] 3 Current NDC, Legacy NDC, 2 package rows 20231128_c2ca033e-fa5f-4141-b702-11f8b4303da1.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 67457-446-10 67457044610 1 VIAL in 1 CARTON (67457-446-10) / 10 mL in 1 VIAL 1 vial 2011-05-10 0000-00-00 No No Current