Minocycline Hydrochloride

Product NDC
67296-1181
Requested package NDC
67296-1181-6
11-digit product format
672961181
Labeler code
67296
Product ID
67296-1181_d60ff571-d1c9-0675-e053-2995a90a15aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA063065
Marketing category
ANDA
Marketing start
1991-12-30
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-118167296-1181-6IInactivated by FDA2026-08-11

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A063065-001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30
A063065-002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A063065-001AB
A063065-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A063065-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A063065-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063065-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063065-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A063065-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A063065-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063065-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063065-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063065-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063065-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063065-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063065-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063065-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063065-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063065-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063065-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063065-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063065-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063065-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A063065-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063065-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063065-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063065-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063065-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063065-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063065-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063065-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A063065-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063065-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063065-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063065-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A063065-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063065-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A063065-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063065-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A063065-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063065-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A063065-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063065-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A063065-002AB1782e0a99824c…

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
67296-1181-12024-01-30C16284748780-11030e365-1389-111a-e063-dadaa90a10e24eca4036-ba54-408e-e054-00144ff8d46c
67296-1181-62024-01-30C16284748780-11030e365-1389-111a-e063-dadaa90a10e24eca4036-ba54-408e-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1181-1Minocycline Hydrochloride14 in 1 BOTTLECAPSULE143
67296-1181-6Minocycline Hydrochloride60 in 1 BOTTLECAPSULE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1181MINOCYCLINE HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]3Legacy NDC, 2 package rows20220121_4eca4036-ba54-408e-e054-00144ff8d46c.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.87a137c6-dd53-44d3-ab49-ef78ebed35c82026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063065
application number: ANDA063065
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEREMEDYREPACK INC.6597bdc9-9e3a-4c11-8b39-27b47f8632872026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063065
application number: ANDA063065
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEActavis Pharma, Inc.a5fc4d50-50b2-46e0-b722-4c6b2ec47d062025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063065
application number: ANDA063065
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack6f154720-706e-4177-8167-1bc893303f1b2024-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063065
application number: ANDA063065
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacka84c29a9-21a8-4965-b5a5-37b28e4af5a02019-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063065
application number: ANDA063065

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN4eca4036-ba54-408e-e054-00144ff8d46c3
197984minocycline 100 MG Oral CapsuleSCD4eca4036-ba54-408e-e054-00144ff8d46c3
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY4eca4036-ba54-408e-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1181-66729611810660 CAPSULE in 1 BOTTLE (67296-1181-6) 60 capsule1991-12-300000-00-00NoNoCurrent