Fossaoprin SPG2

Product NDC
70529-016
11-digit product format
705290016
Labeler code
70529
Product ID
70529-016_9b1587e0-7ddd-4c19-a5b2-77a3981f55ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine hydrochloride, Bupivacaine hydrochloride
Dosage form
KIT
Labeler
IT3 Medical LLC
Application
ANDA088327
Marketing category
ANDA
Marketing start
2017-03-01
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#

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 productproduct70529-016IInactivated by FDA2026-08-03
excluded packagepackage70529-01670529-016-01IInactivated by FDA2026-08-03

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 packagepackage70529-016-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70529-016-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70529-016-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70529-016-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70529-016-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70529-016-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70529-016-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70529-016-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70529-016-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70529-016-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70529-016-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70529-016-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70529-016-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70529-016-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70529-016-011332a3947898…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
A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE2%INJECTABLE / INJECTIONAP1984-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A088327-001AP

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 UTC2026-02A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31cb3db0bc1861…

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 UTC2026-02A088327-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088327-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088327-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088327-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088327-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088327-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088327-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088327-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088327-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088327-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088327-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088327-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088327-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088327-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088327-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088327-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088327-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088327-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088327-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088327-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088327-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A088327-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088327-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088327-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088327-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A088327-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088327-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088327-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088327-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088327-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088327-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088327-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088327-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088327-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088327-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088327-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088327-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088327-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088327-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088327-001AP1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70529-016-01Fossaoprin SPG21 in 1 PACKAGEKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70529-016FOSSAOPRIN SPG2 (LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE) KIT [IT3 MEDICAL LLC]3Legacy NDC, 1 package rows20220302_5c32df04-cf50-45d5-9260-308ba585c407.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.3b2dd84e-cee8-4e58-d494-395a65a353a02026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42d9e4cf-ca73-ec6d-e063-6394a90ae9372025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSHenry Schein, Inc.bb53bb10-bb36-4c9b-b632-71455615f9f32025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
1% LIDOCAINE HCI1% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst999b1c7b-3495-926a-e053-2a95a90ab2062025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
2% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst78d8fb0a-bfae-6599-e053-2991aa0a2e032024-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC8968c61e-2686-0fe6-e053-2a95a90a15fa2023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC858f3faa-e56e-51f9-e053-2a91aa0aa7212023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN5c32df04-cf50-45d5-9260-308ba585c4073
797544isopropyl alcohol 70 % Medicated PadPSN5c32df04-cf50-45d5-9260-308ba585c4073
1010671lidocaine HCl 2 % Injectable SolutionPSN5c32df04-cf50-45d5-9260-308ba585c4073
1012406Marcaine 0.5 % Injectable SolutionPSN5c32df04-cf50-45d5-9260-308ba585c4073
1012406bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine]SBD5c32df04-cf50-45d5-9260-308ba585c4073
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD5c32df04-cf50-45d5-9260-308ba585c4073
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD5c32df04-cf50-45d5-9260-308ba585c4073
1010671lidocaine hydrochloride 20 MG/ML Injectable SolutionSCD5c32df04-cf50-45d5-9260-308ba585c4073
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY5c32df04-cf50-45d5-9260-308ba585c4073
797544isopropyl alcohol 70 % Medicated PadSY5c32df04-cf50-45d5-9260-308ba585c4073
797544isopropyl alcohol 70 % Topical ClothSY5c32df04-cf50-45d5-9260-308ba585c4073
797544isopropyl alcohol 70 % Topical SwabSY5c32df04-cf50-45d5-9260-308ba585c4073
1010671lidocaine hydrochloride 2 % Injectable SolutionSY5c32df04-cf50-45d5-9260-308ba585c4073
1012406Marcaine 0.5 % Injectable SolutionSY5c32df04-cf50-45d5-9260-308ba585c4073
1012406Marcaine 5 MG/ML Injectable SolutionSY5c32df04-cf50-45d5-9260-308ba585c4073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70529-016-01705290016011 KIT in 1 PACKAGE (70529-016-01) * 50 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET * 50 mL in 1 VIAL, MULTI-DOSE1 kit2017-03-010000-00-00NoNoCurrent