Vitamin Deficiency Injectable System - B12

Product NDC
70529-290
11-digit product format
705290290
Labeler code
70529
Product ID
70529-290_b2695b74-358c-4cc6-92a5-a18d9b350b90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyanocobalamin
Dosage form
KIT
Labeler
IT3 Medical LLC
Application
ANDA080515
Marketing category
ANDA
Marketing start
2016-05-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70529-290IInactivated by FDA2026-08-03
excluded packagepackage70529-29070529-290-01IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 18 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct70529-290IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70529-29070529-290-01IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct70529-290IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70529-29070529-290-01IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct70529-290IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70529-29070529-290-01IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct70529-290IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70529-29070529-290-01IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct70529-290IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70529-29070529-290-01IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct70529-290IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70529-29070529-290-01IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct70529-290IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70529-29070529-290-01IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct70529-290IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70529-29070529-290-01IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct70529-290IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70529-29070529-290-01IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
A080515-002CYANOCOBALAMINCYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A080515-002AP

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 UTC2026-02A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080515-002CYANOCOBALAMIN1MG/MLINJECTABLE / INJECTIONAPApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A080515-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080515-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080515-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080515-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080515-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080515-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080515-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080515-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080515-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080515-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080515-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080515-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080515-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080515-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080515-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080515-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080515-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080515-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080515-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080515-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080515-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A080515-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080515-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080515-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080515-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A080515-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A080515-002AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080515-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080515-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080515-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080515-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080515-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080515-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080515-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A080515-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A080515-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080515-002AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080515-002AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080515-002AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080515-002AP1cb3db0bc1861…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst953aa8c6-31ce-0c3b-e053-2a95a90ab35f2024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080515
application number: ANDA080515
CyanocobalaminCYANOCOBALAMINHikma Pharmaceuticals USA Inc.a66eb3c4-3e1d-4d49-b963-4fa2334cc9b62023-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080515
application number: ANDA080515

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9621-01Vitamin Deficiency Injectable System - B121 mL in 1 VIALINJECTION1 mL1000 ug in 1mL4
68599-5804-1Vitamin Deficiency Injectable System - B121 mL in 1 PACKETSWAB2 mL0.7 mL in 1mL4
70529-290-01Vitamin Deficiency Injectable System - B121 in 1 PACKAGEKIT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70529-290-01EA - Each70529-29053cf9737-8bca-40ac-a5eb-6e957e514e8912017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70529-290VITAMIN DEFICIENCY INJECTABLE SYSTEM - B12 (CYANOCOBALAMIN) KIT [IT3 MEDICAL LLC]4Legacy NDC, 3 package rows20220302_579bd1fe-51a1-403f-a422-0fb701aab57d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSN579bd1fe-51a1-403f-a422-0fb701aab57d4
797544isopropyl alcohol 70 % Medicated PadPSN579bd1fe-51a1-403f-a422-0fb701aab57d4
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD579bd1fe-51a1-403f-a422-0fb701aab57d4
309594vitamin B12 1 MG/ML Injectable SolutionSCD579bd1fe-51a1-403f-a422-0fb701aab57d4
309594cyanocobalamin 1 MG/ML Injectable SolutionSY579bd1fe-51a1-403f-a422-0fb701aab57d4
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSY579bd1fe-51a1-403f-a422-0fb701aab57d4
797544isopropyl alcohol 70 % Medicated PadSY579bd1fe-51a1-403f-a422-0fb701aab57d4
797544isopropyl alcohol 70 % Topical ClothSY579bd1fe-51a1-403f-a422-0fb701aab57d4
797544isopropyl alcohol 70 % Topical SwabSY579bd1fe-51a1-403f-a422-0fb701aab57d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9621-01001439621011 mL in 1 VIAL1 mlHistorical
68599-5804-1685995804011 mL in 1 PACKET1 mlHistorical
70529-290-01705290290011 KIT in 1 PACKAGE (70529-290-01) * 1 mL in 1 VIAL (0143-9621-01) * 1 mL in 1 PACKET (68599-5804-1) 1 kit2016-05-010000-00-00NoNoCurrent