MINOCYCLINE HYDROCHLORIDE

Manufacturer
DirectRX
Effective date
2023-04-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 20:48:28

Label at a glance#

ProductMINOCYCLINE HYDROCHLORIDE
Active ingredientMINOCYCLINE HYDROCHLORIDE
Label structure3 sections

Label contents#

Full prescribing information#

SPL Unclassified

SPL UNCLASSIFIED SECTION

Rx only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

270270

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61919-270-3061919-270-30

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
197984minocycline HCl 100 MG Oral CapsulePSN7
197984minocycline 100 MG Oral CapsuleSCD7
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MINOCYCLINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230112

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
9e423e97-a6d9-7bb0-0dcb-343af7c0ff92Product name220230322
472a6924-c7ed-850b-32ce-a510e887fbf9Product name420230207
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-270-202025-01-30C16284748780-12cef2736-8b00-d83d-e063-dadaa90ab31fMINOCYCLINE HYDROCHLORIDE
61919-270-302025-01-30C16284748780-12cef2736-8b00-d83d-e063-dadaa90ab31fMINOCYCLINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-270-20MINOCYCLINE HYDROCHLORIDE20 in 1 BOTTLECAPSULE207
61919-270-30MINOCYCLINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-270MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]7Legacy NDC, 2 package rows20230418_25c33cb5-4244-3721-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-270-20EA - Each61919-270150d4e37-6b53-48e1-bf2b-f65c3b59d00612018-04-19
61919-270-30EA - Each61919-2702c3b3013-38d7-4180-ba07-99deb5d3233e12022-07-06
13668-484-05EA - Each13668-484459a8344-2015-436f-ac1c-694ce87b17e512016-03-04
13668-484-50EA - Each13668-4843d8b7a6b-c518-41a4-8b43-f3002f613bc312016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5U1
MINOCYCLINEACTIVE MOIETYFYY3R43WGO1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GELATININACTIVE INGREDIENT2G86QN327L1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SHELLACINACTIVE INGREDIENT46N107B71O1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-27061919-270-20, 61919-270-30
13668-484

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 mgExact identifier — unii+route+dosage form
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii+route+dosage form
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii+route+dosage form
SHELLACSHELLAC46N107B71OCAPSULE / ORAL34.48 mgExact identifier — unii+route+dosage form
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE / ORAL172 mgExact identifier — unii+route+dosage form
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route+dosage form

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065062-001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-30
A065062-002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-30
A065062-003MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065062-001AB
A065062-002AB
A065062-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-3084e616aacf4f…
2026-09-14 22:38:342026-08A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-3084e616aacf4f…
2026-09-14 22:38:342026-08A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-3084e616aacf4f…
2026-08-18 06:07:402026-07A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-30301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065062-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065062-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A065062-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A065062-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065062-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065062-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065062-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065062-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065062-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065062-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065062-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065062-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065062-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065062-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065062-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065062-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065062-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065062-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065062-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065062-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065062-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065062-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065062-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065062-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065062-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065062-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065062-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065062-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065062-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065062-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065062-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065062-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065062-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065062-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065062-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065062-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065062-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065062-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065062-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065062-001AB1301d65b070ca…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDETorrent Pharmaceuticals Limited55df55fb-18ec-4e00-9ed0-10bba0da513b2026-04-02Warnings, Adverse reactionsExact identifier
ndc (product): 13668-484
f98af2e8-8ca4-75e2-e053-6394a90a506325c33cb5-4244-3721-e054-00144ff8d46c2023-04-17Warnings, Adverse reactionsExact identifier
spl id: f98af2e8-8ca4-75e2-e053-6394a90a5063
spl set id: 25c33cb5-4244-3721-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.