MAS CARE-PAK DEXAMETHASONE

Product NDC
69677-071
11-digit product format
696770071
Labeler code
69677
Product ID
69677-071_5d6b905f-ed32-1ab7-e053-2a91aa0a816b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
KIT
Route
INTRAMUSCULAR; INTRAVENOUS; TOPICAL
Labeler
MAS Management Group Inc.
Application
ANDA040491
Marketing category
ANDA
Marketing start
2017-11-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct69677-071IInactivated by FDA2026-08-17
excluded packagepackage69677-07169677-071-02IInactivated by FDA2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69677-071-02IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69677-071-02IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69677-071-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69677-071-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69677-071-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69677-071-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69677-071-02IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69677-071-02IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69677-071-02IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69677-071-02IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69677-071-02IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69677-071-02IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69677-071-02IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69677-071-02IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69677-071-02IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69677-071-02IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69677-071-02IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69677-071-02IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69677-071-02IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69677-071-02IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69677-071-02IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69677-071-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEDEXAMETHASONE SODIUM PHOSPHATEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040491-001AP

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-113f01610625f2…
2019-09-15 20:21 UTC2019-09A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040491-001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEEQ 10MG PHOSPHATE/MLINJECTABLE / INJECTIONAPRS2003-04-11e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040491-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040491-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040491-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040491-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040491-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040491-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040491-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040491-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040491-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040491-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040491-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040491-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040491-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040491-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040491-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040491-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040491-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040491-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040491-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040491-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040491-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040491-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040491-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040491-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040491-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040491-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040491-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040491-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040491-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040491-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040491-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040491-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040491-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040491-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040491-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040491-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040491-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040491-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040491-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040491-001AP1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69677-071-022020-01-31C16284748780-19d75b9d0-6eb9-f424-e053-dadaa90a57ceMAS CARE-PAK DEXAMETHASONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-121-14MAS CARE-PAK DEXAMETHASONE0.55 mL in 1 POUCHSWAB1.65 mL0.7 mL in 1mL1
69677-071-02MAS CARE-PAK DEXAMETHASONE1 in 1 BOXKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69677-071-02EA - Each69677-071720638f4-2be2-4663-b10b-93e05d30a82212018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69677-071MAS CARE-PAK DEXAMETHASONE (DEXAMETHASONE SODIUM PHOSPHATE) KIT [MAS MANAGEMENT GROUP INC.]1Legacy NDC, 2 package rows20171207_5d6b905f-ed31-1ab7-e053-2a91aa0a816b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLCcca2c160-9188-48e8-9505-49a52388dcb72026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040491
application number: ANDA040491
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLC7cbd9005-7df2-47ee-adb3-7244c1c69bc32026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040491
application number: ANDA040491
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESportpharm LLC6c7ff5f7-5688-4fc4-9194-9e6b8e6fab592026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040491
application number: ANDA040491
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESportpharm LLC56bdd2f3-ae94-4fd9-9d05-5b53263a09c12026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040491
application number: ANDA040491

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812079dexAMETHasone sodium phosphate 10 MG in 1 ML InjectionPSN5d6b905f-ed31-1ab7-e053-2a91aa0a816b1
797544isopropyl alcohol 70 % Medicated PadPSN5d6b905f-ed31-1ab7-e053-2a91aa0a816b1
797730povidone-iodine 10 % Medicated PadPSN5d6b905f-ed31-1ab7-e053-2a91aa0a816b1
18120791 ML dexamethasone phosphate 10 MG/ML InjectionSCD5d6b905f-ed31-1ab7-e053-2a91aa0a816b1
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD5d6b905f-ed31-1ab7-e053-2a91aa0a816b1
797730povidone-iodine 100 MG/ML Medicated PadSCD5d6b905f-ed31-1ab7-e053-2a91aa0a816b1
1812079dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML InjectionSY5d6b905f-ed31-1ab7-e053-2a91aa0a816b1
797544isopropyl alcohol 70 % Medicated PadSY5d6b905f-ed31-1ab7-e053-2a91aa0a816b1
797544isopropyl alcohol 70 % Topical ClothSY5d6b905f-ed31-1ab7-e053-2a91aa0a816b1
797544isopropyl alcohol 70 % Topical SwabSY5d6b905f-ed31-1ab7-e053-2a91aa0a816b1
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY5d6b905f-ed31-1ab7-e053-2a91aa0a816b1
797730povidone-iodine 10 % Medicated PadSY5d6b905f-ed31-1ab7-e053-2a91aa0a816b1
797730povidone-iodine 10 % Medicated SwabstickSY5d6b905f-ed31-1ab7-e053-2a91aa0a816b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67777-121-14677770121140.55 mL in 1 POUCH0.55 mlHistorical
69677-071-02696770071021 in 1 BOXHistorical