Home NDC 67457-437 Doxycycline
Product NDC 67457-437
11-digit product format 674570437
Labeler code 67457
Product ID 67457-437_58f9b611-c70f-4606-acdc-32f1f8f1facb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA091406
Marketing category ANDA
Marketing start 2018-12-20
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 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
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 67457-437-00 Doxycycline 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 10 67457-437-10 Doxycycline 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE HYCLATE ACTIVE INGREDIENT 19XTS3T51U DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ] 3 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ] 3 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-437 DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 10 Current NDC, Legacy NDC, 2 package rows 20250117_878a1cf9-31a9-425b-910d-042ed91e98d5.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 67457-437-00 67457043700 10 mL in 1 VIAL 10 ml Historical 67457-437-10 67457043710 10 VIAL in 1 CARTON (67457-437-10) / 10 mL in 1 VIAL (67457-437-00) 10 vial 2018-12-20 0000-00-00 No No Current