Pamidronate Disodium

Product NDC
61703-325
11-digit product format
617030325
Labeler code
61703
Product ID
61703-325_d1f55dd9-cc5b-4162-81be-53736ffbb5a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PAMIDRONATE DISODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA075841
Marketing category
ANDA
Marketing start
2003-07-28
Substance
PAMIDRONATE DISODIUM
Active strength
6 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075841-001PAMIDRONATE DISODIUMPAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-27
A075841-002PAMIDRONATE DISODIUMPAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-27
A075841-003PAMIDRONATE DISODIUMPAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075841-001AP2
A075841-002AP
A075841-003AP2

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 22:38:342026-08A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-2784e616aacf4f…
2026-09-14 22:38:342026-08A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-2784e616aacf4f…
2026-09-14 22:38:342026-08A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-2784e616aacf4f…
2026-08-18 06:07:402026-07A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075841-002PAMIDRONATE DISODIUM60MG/10ML (6MG/ML)INJECTABLE / INJECTIONAPRS2002-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075841-003PAMIDRONATE DISODIUM90MG/10ML (9MG/ML)INJECTABLE / INJECTIONAP22002-06-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075841-001PAMIDRONATE DISODIUM30MG/10ML (3MG/ML)INJECTABLE / INJECTIONAP22002-06-27301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075841-001AP2184e616aacf4f…
2026-09-14 22:38:342026-08A075841-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A075841-003AP2184e616aacf4f…
2026-08-18 06:07:402026-07A075841-001AP21caaa826d4ba7…
2026-08-18 06:07:402026-07A075841-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A075841-003AP21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075841-001AP21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075841-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075841-003AP21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075841-001AP2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075841-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075841-003AP2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075841-001AP216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075841-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075841-003AP216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075841-001AP21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075841-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075841-003AP21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075841-001AP21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075841-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075841-003AP21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075841-001AP2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075841-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075841-003AP2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075841-001AP212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075841-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075841-003AP212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075841-001AP215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075841-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075841-003AP215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075841-001AP21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075841-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075841-003AP21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075841-001AP21d06236e962d9…
2024-10-29 15:01 UTC2024-10A075841-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075841-003AP21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075841-001AP2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075841-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075841-003AP2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075841-001AP21301d65b070ca…

Additional Listing Data#

Finished product
Yes
Brand name base
Pamidronate Disodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAMIDRONATE DISODIUM6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8742T8ZQZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737449Internal RxNorm lookup
1737451Internal RxNorm lookup
1737453Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f179c5f-e388-9738-290f-dc1652172ebdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61703-325-18Pamidronate Disodium1 in 1 CARTONINJECTION, SOLUTION124
61703-325-18Pamidronate Disodium10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61703-325-18ML - Milliliter61703-325fae7e9a8-d04c-4fab-a845-fbda4ba9320c12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61703-325PAMIDRONATE DISODIUM INJECTION, SOLUTION [HOSPIRA, INC.]22Current NDC, Legacy NDC, 2 package rows20250110_9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pamidronate DisodiumPAMIDRONATE DISODIUMHospira, Inc.9b6a9a3b-71c9-4dcb-b857-5d1de25c3a232026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075841
application number: ANDA075841
ndc (product): 61703-325

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737449pamidronate disodium 30 MG in 10 ML InjectionPSN9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
1737451pamidronate disodium 60 MG in 10 ML InjectionPSN9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
1737453pamidronate disodium 90 MG in 10 ML InjectionPSN9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
173744910 ML pamidronate disodium 3 MG/ML InjectionSCD9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
173745110 ML pamidronate disodium 6 MG/ML InjectionSCD9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
173745310 ML pamidronate disodium 9 MG/ML InjectionSCD9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
1737449pamidronate disodium 30 MG per 10 ML InjectionSY9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
1737451pamidronate disodium 60 MG per 10 ML InjectionSY9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324
1737453pamidronate disodium 90 MG per 10 ML InjectionSY9b6a9a3b-71c9-4dcb-b857-5d1de25c3a2324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61703-325-18617030325181 VIAL, SINGLE-DOSE in 1 CARTON (61703-325-18) / 10 mL in 1 VIAL, SINGLE-DOSE2003-07-280000-00-00NoNoCurrent