Minocycline Hydrochloride

Product NDC
68071-3635
Requested package NDC
68071-3635-3
11-digit product format
680713635
Labeler code
68071
Product ID
68071-3635_2abca736-08a4-e465-e063-6294a90a0b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065062
Marketing category
ANDA
Marketing start
2015-04-02
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
50 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 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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE50 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
197985Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1c363cbb-099b-7c73-e063-6394a90ae13fAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3635-3Minocycline Hydrochloride30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3635MINOCYCLINE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250104_1c363cbb-099b-7c73-e063-6394a90ae13f.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
ndc (package): 68071-3635-3
ndc (product): 68071-3635
ndc11 (package): 68071363503
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197985minocycline HCl 50 MG Oral CapsulePSN1c363cbb-099b-7c73-e063-6394a90ae13f2
197985minocycline 50 MG Oral CapsuleSCD1c363cbb-099b-7c73-e063-6394a90ae13f2
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSY1c363cbb-099b-7c73-e063-6394a90ae13f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3635-36807136350330 CAPSULE in 1 BOTTLE (68071-3635-3) 30 capsule2024-07-01NoNoCurrent