Minocycline Hydrochloride

Product NDC
71335-0682
11-digit product format
713350682
Labeler code
71335
Product ID
71335-0682_034b4afb-e15a-454e-a13a-8a1397856a53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA063181
Marketing category
ANDA
Marketing start
1992-02-01
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A063181-001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A063181-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-303f01610625f2…
2019-09-15 20:21 UTC2019-09A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A063181-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1991-12-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A063181-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063181-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A063181-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063181-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063181-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063181-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063181-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063181-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063181-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063181-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063181-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063181-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063181-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063181-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063181-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063181-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063181-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063181-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063181-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063181-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063181-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A063181-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A063181-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A063181-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A063181-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A063181-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A063181-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A063181-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A063181-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A063181-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A063181-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A063181-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A063181-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A063181-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A063181-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A063181-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A063181-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A063181-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A063181-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A063181-001AB1cb3db0bc1861…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197984Internal RxNorm lookup
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
a84c29a9-21a8-4965-b5a5-37b28e4af5a0Available 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
71335-0682-1Minocycline Hydrochloride90 in 1 BOTTLECAPSULE902
71335-0682-2Minocycline Hydrochloride50 in 1 BOTTLECAPSULE502
71335-0682-3Minocycline Hydrochloride60 in 1 BOTTLECAPSULE602
71335-0682-4Minocycline Hydrochloride30 in 1 BOTTLECAPSULE302
71335-0682-5Minocycline Hydrochloride100 in 1 BOTTLECAPSULE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0682MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]2Current NDC, Legacy NDC, 5 package rows20190614_a84c29a9-21a8-4965-b5a5-37b28e4af5a0.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1ec20539-0421-4eac-95ed-e9acc6329fd02026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063181
application number: ANDA063181
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEActavis Pharma, Inc.a5fc4d50-50b2-46e0-b722-4c6b2ec47d062025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063181
application number: ANDA063181
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEProficient Rx LPd5fcba91-6aa6-4072-aea5-fb8da65d9aac2022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063181
application number: ANDA063181
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacka84c29a9-21a8-4965-b5a5-37b28e4af5a02019-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063181
application number: ANDA063181
ndc (product): 71335-0682

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSNa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197985minocycline HCl 50 MG Oral CapsulePSNa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197984minocycline 100 MG Oral CapsuleSCDa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197985minocycline 50 MG Oral CapsuleSCDa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYa84c29a9-21a8-4965-b5a5-37b28e4af5a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0682-17133506820190 CAPSULE in 1 BOTTLE (71335-0682-1) 90 capsule2015-09-170000-00-00NoNoCurrent
71335-0682-27133506820250 CAPSULE in 1 BOTTLE (71335-0682-2) 50 capsule2015-09-170000-00-00NoNoCurrent
71335-0682-37133506820360 CAPSULE in 1 BOTTLE (71335-0682-3) 60 capsule2015-09-170000-00-00NoNoCurrent
71335-0682-47133506820430 CAPSULE in 1 BOTTLE (71335-0682-4) 30 capsule2015-09-170000-00-00NoNoCurrent
71335-0682-571335068205100 CAPSULE in 1 BOTTLE (71335-0682-5) 100 capsule2015-09-170000-00-00NoNoCurrent