MINOCYCLINE HYDROCHLORIDE

Product NDC
61919-560
Requested package NDC
61919-560-20
11-digit product format
619190560
Labeler code
61919
Product ID
61919-560_9ca974dc-7412-abc6-e053-2995a90a767f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MINOCYCLINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
ANDA065470
Marketing category
ANDA
Marketing start
2014-01-01
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
2021-12-31
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 packagepackage61919-56061919-560-20IInactivated 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 · 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 · 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 UTC2026-02A065470-001MINOCYCLINE 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-118072bd15b7f6…

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 UTC2026-02A065470-001AB1011fe1cb6892…
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065470-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065470-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065470-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065470-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065470-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065470-001AB18072bd15b7f6…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-560-202023-01-30C16284748780-1f386c649-cdb2-0266-e053-dadaa90a7c1a174d642b-70b1-45b0-ad33-a4847feb1a8f
61919-560-302023-01-30C16284748780-1f386c649-cdb2-0266-e053-dadaa90a7c1a174d642b-70b1-45b0-ad33-a4847feb1a8f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-560-20MINOCYCLINE HYDROCHLORIDE20 in 1 BOTTLECAPSULE203
61919-560-30MINOCYCLINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-560-20EA - Each61919-560e6c26bb0-84a5-4447-a9f4-2e42f2caddb212015-01-05
61919-560-30EA - Each61919-5603db234cf-3ac9-4d2b-b13b-101bf911c29512015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-560MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]3Legacy NDC, 2 package rows20200130_174d642b-70b1-45b0-ad33-a4847feb1a8f.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
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 CapsulePSN174d642b-70b1-45b0-ad33-a4847feb1a8f3
197984minocycline 100 MG Oral CapsuleSCD174d642b-70b1-45b0-ad33-a4847feb1a8f3
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY174d642b-70b1-45b0-ad33-a4847feb1a8f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-560-206191905602020 CAPSULE in 1 BOTTLE (61919-560-20) 20 capsule2014-01-010000-00-00NoNoCurrent