IBANDRONATE SODIUM

Product NDC
62756-218
Requested package NDC
62756-218-40
11-digit product format
627560218
Labeler code
62756
Product ID
62756-218_61378ee8-cc2f-4f55-954b-4eb55e975f5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBANDRONATE SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090853
Marketing category
ANDA
Marketing start
2014-02-15
Substance
IBANDRONATE SODIUM
Active strength
3 mg/3mL
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 21 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090853-001IBANDRONATE SODIUMIBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-14

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUS2014-02-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-143f01610625f2…
2019-09-15 20:21 UTC2019-09A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090853-001IBANDRONATE SODIUMEQ 3MG BASE/3MLINJECTABLE / INTRAVENOUSAP2014-02-14cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A090853-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090853-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090853-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090853-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090853-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090853-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090853-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090853-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A090853-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090853-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090853-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090853-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A090853-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090853-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090853-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090853-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090853-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090853-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090853-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090853-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090853-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090853-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090853-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090853-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090853-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090853-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090853-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
IBANDRONATE SODIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBANDRONATE SODIUM3 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J12U072QL0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
904955Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
be514be6-727a-4d6c-993b-52144f8e6de8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
fca0fe5b-9e2b-f6fc-e68d-b5f751d08578Product name320180103
a7e2afc7-9184-42ab-b6c6-6edca00dd2d2Product name420160310
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-218-40IBANDRONATE SODIUM1 in 1 CARTONINJECTION, SOLUTION16
62756-218-40IBANDRONATE SODIUM3 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-218-40ML - Milliliter62756-218565fb9b7-bd67-4701-add4-fc4a163300bd12014-04-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-218IBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 2 package rows20181026_be514be6-727a-4d6c-993b-52144f8e6de8.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
IBANDRONATE SODIUMIBANDRONATE SODIUMSun Pharmaceutical Industries, Inc.be514be6-727a-4d6c-993b-52144f8e6de82026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090853
application number: ANDA090853
ndc (package): 62756-218-40
ndc (product): 62756-218
ndc11 (package): 62756021840

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904955ibandronate sodium 3 MG in 3 ML InjectionPSNbe514be6-727a-4d6c-993b-52144f8e6de86
9049553 ML ibandronic acid 1 MG/ML InjectionSCDbe514be6-727a-4d6c-993b-52144f8e6de86
904955ibandronic acid 1 MG/ML (as ibandronate sodium 1.13 MG/ML) InjectionSYbe514be6-727a-4d6c-993b-52144f8e6de86
904955ibandronic acid 3 MG per 3 ML (as ibandronate sodium 1.13 MG/ML) InjectionSYbe514be6-727a-4d6c-993b-52144f8e6de86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62756-218-40627560218401 VIAL, SINGLE-DOSE in 1 CARTON (62756-218-40) / 3 mL in 1 VIAL, SINGLE-DOSE2014-02-15NoNoCurrent