Minocin

Product NDC
65293-014
11-digit product format
652930014
Labeler code
65293
Product ID
65293-014_9edb5ed1-a9ae-1af3-e053-2a95a90a722e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
minocycline hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
The Medicines Company
Application
NDA050444
Marketing category
NDA
Marketing start
2013-04-19
Marketing end
2020-09-30
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct65293-014DDiscontinued by firm2026-08-17
excluded packagepackage65293-01465293-014-10DDiscontinued by firm2026-08-17

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 · 26 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65293-014-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65293-014-10DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65293-014-10DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65293-014-10DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65293-014-10DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65293-014-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65293-014-10DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65293-014-10DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65293-014-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65293-014-10DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65293-014-10DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65293-014-10DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
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 packagepackage65293-014-10EExcluded 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
N050444-001MINOCINMINOCYCLINE HYDROCHLORIDEEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N050444-001121616562031-05-12Drug product2024-12-18
N050444-00190848022031-05-12U-2822015-07-23
N050444-00192781052031-05-12U-2822016-03-16
N050444-001119446342032-10-16Drug product2024-04-02

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 06:07:402026-07N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050444-001MINOCINEQ 100MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050444-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050444-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050444-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050444-001AP12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050444-001AP1d8e5a09893c0…
2023-05-13 08:27 UTC2023-05N050444-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N050444-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050444-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050444-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050444-001AP1e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N050444-001121616562031-05-12Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N050444-00190848022031-05-12U-2822015-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07N050444-00192781052031-05-12U-2822016-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N050444-001119446342032-10-16Drug product2024-04-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050444-001121616562031-05-12Drug product2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050444-00190848022031-05-12U-2822015-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050444-00192781052031-05-12U-2822016-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050444-001119446342032-10-16Drug product2024-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050444-001121616562031-05-12Drug product2024-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050444-00190848022031-05-12U-2822015-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050444-00192781052031-05-12U-2822016-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050444-001119446342032-10-16Drug product2024-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050444-001121616562031-05-12Drug product2024-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050444-00190848022031-05-12U-2822015-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050444-00192781052031-05-12U-2822016-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050444-001119446342032-10-16Drug product2024-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050444-001121616562031-05-12Drug product2024-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050444-00190848022031-05-12U-2822015-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050444-00192781052031-05-12U-2822016-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050444-001119446342032-10-16Drug product2024-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050444-001121616562031-05-12Drug product2024-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050444-00190848022031-05-12U-2822015-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050444-00192781052031-05-12U-2822016-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050444-001119446342032-10-16Drug product2024-04-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050444-001121616562031-05-12Drug product2024-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050444-00190848022031-05-12U-2822015-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050444-00192781052031-05-12U-2822016-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050444-001119446342032-10-16Drug product2024-04-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050444-00190848022031-05-12U-2822015-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050444-00192781052031-05-12U-2822016-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050444-001119446342032-10-16Drug product2024-04-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050444-00190848022031-05-12U-2822015-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050444-00192781052031-05-12U-2822016-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050444-001119446342032-10-16Drug product2024-04-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050444-00190848022031-05-12U-2822015-07-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050444-00192781052031-05-12U-2822016-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050444-001119446342032-10-16Drug product2024-04-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050444-00190848022031-05-12U-2822015-07-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N050444-00192781052031-05-12U-2822016-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N050444-001119446342032-10-16Drug product2024-04-02d06236e962d9…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65293-014-01EA - Each65293-01473d80cde-d8b1-409c-9685-d0b7e668667112015-08-04
65293-014-10EA - Each65293-01453b7dc5e-e877-446b-af17-58065735038a12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCIN (MINOCYCLINE HYDROCHLORIDE) INJECTION [THE MEDICINES COMPANY]6
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCIN (MINOCYCLINE HYDROCHLORIDE) INJECTION [THE MEDICINES COMPANY]6
MAGNESIUM SULFATE HEPTAHYDRATEINACTIVE INGREDIENTSK47B8698TMINOCIN (MINOCYCLINE HYDROCHLORIDE) INJECTION [THE MEDICINES COMPANY]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMINOCIN (MINOCYCLINE HYDROCHLORIDE) INJECTION [THE MEDICINES COMPANY]6

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
MinocinMINOCYCLINE HYDROCHLORIDEMelinta Therapeutics, LLCe415c323-8219-464b-9e3e-72c5a796cdaa2025-09-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 050444
application number: NDA050444