Home NDC 68180-650 DOXYCYCLINE
Product NDC 68180-650
11-digit product format 681800650
Labeler code 68180
Product ID 68180-650_771f820a-2e1b-4a25-91cb-ba7a068abc70
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXYCYCLINE
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA204234
Marketing category ANDA
Marketing start 2015-02-20
Substance DOXYCYCLINE
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204234-001 DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 A204234-002 DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 A204234-003 DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05
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 · 123 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 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204234-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2014-03-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204234-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB 2014-03-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204234-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2014-03-05 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DOXYCYCLINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N12000U13O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 700408 Internal RxNorm lookup 1649401 Internal RxNorm lookup 1649990 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 68180-650-01 DOXYCYCLINE 100 in 1 BOTTLE CAPSULE 100 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-650 DOXYCYCLINE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 15 Current NDC, Legacy NDC, 1 package rows 20241206_bcc65910-30d8-4807-ab61-607a56382924.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-650-01 68180065001 100 CAPSULE in 1 BOTTLE (68180-650-01) 100 capsule 2015-02-20 0000-00-00 No No Current