Pamidronate Disodium

Product NDC
59923-601
11-digit product format
599230601
Labeler code
59923
Product ID
59923-601_b8e43f73-c0bb-ab68-e053-2a95a90a1e8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pamidronate Disodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Areva Pharmaceuticals Inc.
Application
ANDA077433
Marketing category
ANDA
Marketing start
2013-08-06
Marketing end
0000-00-00
Substance
PAMIDRONATE DISODIUM
Active strength
3 mg/mL
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59923-601DDiscontinued by firm2026-09-14
excluded packagepackage59923-60159923-601-10DDiscontinued by firm2026-09-14

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59923-601-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59923-601-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59923-601-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59923-601-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59923-601-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59923-601-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59923-601-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59923-601-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59923-601-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59923-601-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59923-601-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59923-601-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59923-601-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59923-601-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59923-601-101332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077433-001PAMIDRONATE DISODIUMPAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-26
A077433-002PAMIDRONATE DISODIUMPAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-26
A077433-003PAMIDRONATE DISODIUMPAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077433-001AP
A077433-003AP

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-2684e616aacf4f…
2026-09-14 22:38:342026-08A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-2684e616aacf4f…
2026-09-14 22:38:342026-08A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-2684e616aacf4f…
2026-08-18 06:07:402026-07A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077433-002PAMIDRONATE DISODIUM60MG/VIALINJECTABLE / INJECTION2008-11-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077433-003PAMIDRONATE DISODIUM90MG/VIALINJECTABLE / INJECTIONAP2008-11-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077433-001PAMIDRONATE DISODIUM30MG/VIALINJECTABLE / INJECTIONAP2008-11-26301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077433-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A077433-003AP184e616aacf4f…
2026-08-18 06:07:402026-07A077433-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077433-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077433-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077433-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077433-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077433-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077433-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077433-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077433-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077433-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077433-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077433-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077433-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077433-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077433-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077433-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077433-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077433-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077433-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077433-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077433-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077433-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077433-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077433-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077433-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077433-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077433-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077433-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077433-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077433-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077433-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077433-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077433-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077433-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077433-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077433-003AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077433-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077433-003AP174a2ff9319b5…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59923-601-10EA - Each59923-601d4a37f0a-dd89-4869-b379-e29fc054804812014-05-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59923-601PAMIDRONATE DISODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AREVA PHARMACEUTICALS INC.]7Legacy NDC20210115_5db8c103-2bfd-a235-d50d-4c1a356d44d2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59923-601-10599230601101 VIAL, SINGLE-DOSE in 1 CARTON (59923-601-10) > 10 mL in 1 VIAL, SINGLE-DOSE2013-08-060000-00-00NoNoCurrent