Home NDC 0404-9855 DOXYCYCLINE
Product NDC 0404-9855
11-digit product format 004049855
Labeler code 0404
Product ID 0404-9855_b372de2b-d9ea-4e3d-8a18-5e947d2a0078
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxycycline
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Henry Schein, Inc
Application ANDA091406
Marketing category ANDA
Marketing start 2022-01-10
Marketing end 2027-03-31
Substance DOXYCYCLINE HYCLATE
Active strength 100 mg/10mL
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091406-001 DOXYCYCLINE DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091406-001 AP
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 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 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091406-001 DOXYCYCLINE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2012-08-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DOXYCYCLINE Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE HYCLATE 100 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 19XTS3T51U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310027 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 0404-9855-99 DOXYCYCLINE 10 mL in 1 PACKAGE INJECTION, POWDER, LYOPHILIZED, 10 5 0404-9855-99 DOXYCYCLINE 1 in 1 BAG INJECTION, POWDER, LYOPHILIZED, 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9855 DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HENRY SCHEIN, INC] 4 Current NDC, Legacy NDC, 2 package rows 20241018_dd70368b-1949-4833-9d1e-f9f4cdacd9f3.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 Units Marketing start Marketing end Sample Exclude flag Status 0404-9855-99 00404985599 1 PACKAGE in 1 BAG (0404-9855-99) / 10 mL in 1 PACKAGE 1 package 2022-01-10 2027-03-31 No No Current