Home NDC 83634-111 Doxycycline
Product NDC 83634-111
11-digit product format 836340111
Labeler code 83634
Product ID 83634-111_60ade7bd-fba3-413c-a82b-904e2ae98b9b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxycycline
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Avenacy Inc.
Application ANDA217854
Marketing category ANDA
Marketing start 2025-03-01
Substance DOXYCYCLINE HYCLATE
Active strength 100 mg/10mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217854-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217854-001 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.
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 A217854-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217854-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217854-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217854-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217854-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217854-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217854-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217854-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217854-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217854-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217854-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217854-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-07-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Doxycycline
Listing expiration 2026-12-31 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 83634-111-20 Doxycycline 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 1 83634-111-41 Doxycycline 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83634-111 DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AVENACY INC.] 1 Current NDC, 2 package rows 20250302_429813b4-0223-4d85-a844-b1227ff63b1e.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 · 1 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 83634-111-20 83634011120 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-111-20) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-111-41) 2025-03-01 No No Current 83634-111-41 83634011141 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical