Home NDC 63629-5327 Minocycline Hydrochloride
Product NDC 63629-5327
11-digit product format 636295327
Labeler code 63629
Product ID 63629-5327_6880f216-6721-42de-bb21-29a20acd6dde
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Minocycline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA063065
Marketing category ANDA
Marketing start 1999-06-10
Substance MINOCYCLINE HYDROCHLORIDE
Active strength 75 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 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 63629-5327 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63629-5327 63629-5327-2 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63629-5327 63629-5327-1 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A063065-001 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 A063065-002 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Minocycline Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOCYCLINE HYDROCHLORIDE 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0020414E5U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314108 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-5327-1 Minocycline Hydrochloride 30 in 1 BOTTLE CAPSULE 30 1003 63629-5327-2 Minocycline Hydrochloride 60 in 1 BOTTLE CAPSULE 60 1003 63629-5327-3 Minocycline Hydrochloride 16 in 1 BOTTLE CAPSULE 16 1003
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-5327 MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] 1003 Current NDC, 3 package rows 20240906_6f154720-706e-4177-8167-1bc893303f1b.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63629-5327-1 63629532701 30 CAPSULE in 1 BOTTLE (63629-5327-1) 30 capsule 2014-05-02 No No Current 63629-5327-2 63629532702 60 CAPSULE in 1 BOTTLE (63629-5327-2) 60 capsule 2014-05-02 No No Current 63629-5327-3 63629532703 16 CAPSULE in 1 BOTTLE (63629-5327-3) 16 capsule 2014-05-02 No No Current