Minocycline Hydrochloride

Product NDC
55700-415
Requested package NDC
55700-415-60
11-digit product format
557000415
Labeler code
55700
Product ID
55700-415_ef7c40d6-8ad1-498e-b220-4185966c36b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA065062
Marketing category
ANDA
Marketing start
2015-04-02
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 packagepackage55700-41555700-415-60DDiscontinued by firm2026-08-11

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065062-001MINOCYCLINE 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065062-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-11-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065062-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2000-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065062-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-11-308072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065062-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065062-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065062-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065062-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065062-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065062-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-415-14EA - Each55700-41540220dc4-870b-4782-be8d-bd58550d5e6212017-03-06
55700-415-20EA - Each55700-4158d9d6eda-0eac-4d8c-af5a-0a799b7505f212016-12-07
55700-415-30EA - Each55700-415f7459577-112f-446d-a3c7-1b0b1cb7950a12017-03-06
55700-415-60EA - Each55700-4155acca8ac-70ed-4785-b8a6-d235823a859412017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-415MINOCYCLINE HYDROCHLORIDE CAPSULE [QUALITY CARE PRODUCTS LLC]9Legacy NDC20241219_98ccf6d3-4024-4a2e-8655-3ccb28eb46b3.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEMajor Pharamceuticalsfd86ff45-37d0-4501-b9fb-e1836e4a8be42026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack093ff3c7-3ecc-47b4-9ae6-5218bcd262b22026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack65767ae3-b1ed-4492-90f2-703b2c7e0f382026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7e2390b7-242c-43ff-afb3-b0a5e79351d32026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEA-S Medication Solutionsc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad2026-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDETorrent Pharmaceuticals Limited55df55fb-18ec-4e00-9ed0-10bba0da513b2026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack6b2a7493-2e6c-4901-b697-17eb188cc8dd2025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAmerican Health Packaging94d941e3-d3d8-4414-bd5c-4a92848e738f2025-07-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ec93ad27-aff5-cbc7-e053-2a95a90adc7e2025-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1c363cbb-099b-7c73-e063-6394a90ae13f2025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062
Minocycline hydrochlorideMINOCYCLINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf901a1ba-1716-8795-e053-6294a90a4e772024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062
Minocycline hydrochlorideMINOCYCLINE HYDROCHLORIDEProficient Rx LPe6b04358-0f4c-4b21-a7f3-320d1e7bc0b82021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEProficient Rx LPd67e4b17-7d44-4d72-9150-420d98cc6db32019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065062
application number: ANDA065062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-415-605570004156060 CAPSULE in 1 BOTTLE (55700-415-60) 60 capsule2017-08-250000-00-00NoNoCurrent