Home NDC 63304-697 Minocycline Hydrochloride
Product NDC 63304-697
11-digit product format 633040697
Labeler code 63304
Product ID 63304-697_4a8d201f-b0b6-4463-af35-8f241caf048b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Minocycline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ranbaxy Pharmaceuticals Inc.
Application ANDA065156
Marketing category ANDA
Marketing start 2004-06-29
Marketing end 0000-00-00
Substance MINOCYCLINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065156-001 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 A065156-002 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 A065156-003 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 2026-09-14 22:38:34 2026-08 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63304-697-01 Minocycline Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 4 63304-697-05 Minocycline Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MINOCYCLINE HYDROCHLORIDE ACTIVE INGREDIENT 0020414E5U MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4 MINOCYCLINE ACTIVE MOIETY FYY3R43WGO MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-697 MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 4 Legacy NDC, 2 package rows 20111025_b4db7cdc-bcad-4825-9840-6c36246c6d31.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 63304-697-01 63304069701 100 in 1 BOTTLE Historical 63304-697-05 63304069705 500 in 1 BOTTLE Historical