Minocycline Hydrochloride

Product NDC
80425-0390
Requested package NDC
80425-0390-2
11-digit product format
804250390
Labeler code
80425
Product ID
80425-0390_19233bc0-9973-2002-e063-6394a90a057c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA065470
Marketing category
ANDA
Marketing start
2024-05-23
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 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
A065470-001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11
A065470-002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11
A065470-003MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065470-001AB
A065470-002AB
A065470-003AB

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 22:38:342026-08A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-1184e616aacf4f…
2026-09-14 22:38:342026-08A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-1184e616aacf4f…
2026-09-14 22:38:342026-08A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-1184e616aacf4f…
2026-08-18 06:07:402026-07A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11301d65b070ca…

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 22:38:342026-08A065470-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065470-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A065470-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A065470-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065470-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065470-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065470-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065470-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065470-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065470-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065470-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065470-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065470-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065470-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065470-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065470-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065470-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065470-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065470-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065470-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065470-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065470-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065470-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065470-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065470-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065470-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065470-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065470-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065470-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065470-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065470-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065470-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065470-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065470-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065470-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065470-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065470-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065470-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065470-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065470-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Minocycline Hydrochloride
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197984Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
192327c5-d2bc-1bd1-e063-6394a90a110bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0390-1Minocycline Hydrochloride30 in 1 BOTTLECAPSULE301
80425-0390-2Minocycline Hydrochloride60 in 1 BOTTLECAPSULE601
80425-0390-3Minocycline Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0390-1EA - Each80425-039071fe8381-bc34-4a90-9350-e4076beeac5c12024-07-12
80425-0390-2EA - Each80425-03908a72d2c2-2243-4847-91a9-9faaf4e71be812024-07-12
80425-0390-3EA - Each80425-0390d4022afc-f65f-42d3-b4a7-3080266a1d2212024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0390MINOCYCLINE HYDROCHLORIDE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 3 package rows20240601_192327c5-d2bc-1bd1-e063-6394a90a110b.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.caa99901-467c-4e99-b7e9-fbabdf5d118c2026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEREMEDYREPACK INC.0becbde8-6ec5-4830-a0d9-cfdb7b15eb842026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackbb3b9a7e-6724-4c2a-b3cb-236f522b31a82026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEA-S Medication Solutionsc96b1c5d-7004-4ee2-ad48-0ba963389f862026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLC12559b29-6568-4b99-a16e-6a87038981f72026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAurobindo Pharma Limited9013ca48-15f2-43cd-a51d-91cf65c72a7c2025-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackd00d9bc4-c764-4ec1-beb0-44668637bcfb2025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacka6224eeb-25be-4f1d-889f-809aaf338c8c2024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.abaacdeb-2433-261a-e053-2995a90ae34e2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC192327c5-d2bc-1bd1-e063-6394a90a110b2024-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
ndc (package): 80425-0390-2
ndc (product): 80425-0390
ndc11 (package): 80425039002
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEProficient Rx LP4f904969-5af3-461e-b557-d03a1e5c72922023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN192327c5-d2bc-1bd1-e063-6394a90a110b1
197984minocycline 100 MG Oral CapsuleSCD192327c5-d2bc-1bd1-e063-6394a90a110b1
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY192327c5-d2bc-1bd1-e063-6394a90a110b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0390-28042503900260 CAPSULE in 1 BOTTLE (80425-0390-2) 60 capsule2024-05-23NoNoCurrent