Minocin

Product NDC
70842-160
11-digit product format
708420160
Labeler code
70842
Product ID
70842-160_07795bdf-7c92-445b-8b8b-d22c5c3eae7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
minocycline hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Melinta Therapeutics, LLC
Application
NDA050444
Marketing category
NDA
Marketing start
2013-04-19
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Minocin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0020414E5UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
207358Internal RxNorm lookup
317127Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e415c323-8219-464b-9e3e-72c5a796cdaaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
9e423e97-a6d9-7bb0-0dcb-343af7c0ff92Product name220230322
472a6924-c7ed-850b-32ce-a510e887fbf9Product name420230207
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
f1239550-2d2e-44c3-aec7-14fd9b4ab55dProduct name120201103
7a57513a-a145-4b95-9165-1e0ef21d6017Product name120200326
70555e58-6951-4421-9354-f80c6ce0d92cProduct name720200204
23de08d7-aa4e-ec8b-ce6d-2124a855e4efProduct name520180605
76736e48-254d-4a39-993d-206efbdaad1dProduct name120170717
0c498039-5512-d9d7-e6b6-833de47219ffProduct name220151106
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70842-160-01Minocin1 in 1 VIALINJECTION111
70842-160-10Minocin10 in 1 CARTONINJECTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70842-160-01EA - Each70842-160f85def63-b347-44fd-bfe8-4ffbedb91ed412018-09-05
70842-160-10EA - Each70842-1603e16c072-4345-41d6-8206-090c9d38e5ad12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70842-160MINOCIN (MINOCYCLINE HYDROCHLORIDE) INJECTION [MELINTA THERAPEUTICS, LLC]10Current NDC, Legacy NDC, 2 package rows20250409_e415c323-8219-464b-9e3e-72c5a796cdaa.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
MinocinMINOCYCLINE HYDROCHLORIDEMelinta Therapeutics, LLCe415c323-8219-464b-9e3e-72c5a796cdaa2025-09-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 050444
application number: NDA050444
ndc (product): 70842-160

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207358Minocin 100 MG InjectionPSNe415c323-8219-464b-9e3e-72c5a796cdaa11
317127minocycline 100 MG InjectionPSNe415c323-8219-464b-9e3e-72c5a796cdaa11
207358minocycline 100 MG Injection [Minocin]SBDe415c323-8219-464b-9e3e-72c5a796cdaa11
317127minocycline 100 MG InjectionSCDe415c323-8219-464b-9e3e-72c5a796cdaa11
207358Minocin 100 MG InjectionSYe415c323-8219-464b-9e3e-72c5a796cdaa11
317127minocycline (as minocycline hydrochloride) 100 MG InjectionSYe415c323-8219-464b-9e3e-72c5a796cdaa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70842-160-01708420160011 in 1 VIALHistorical
70842-160-107084201601010 VIAL in 1 CARTON (70842-160-10) / 1 INJECTION in 1 VIAL (70842-160-01) 10 vial2013-04-190000-00-00NoNoCurrent