Home NDC 51662-1402 DOXY 100(TM) DOXYCYCLINE
Product NDC 51662-1402
11-digit product format 516621402
Labeler code 51662
Product ID 51662-1402_1035c9ce-0312-9d8b-e063-6394a90a8736
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXY 100(TM) DOXYCYCLINE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA062475
Marketing category ANDA
Marketing start 2019-10-07
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062475-001 DOXY 100 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 A062475-002 DOXY 200 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062475-001 DOXY 100 EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A062475-002 DOXY 200 EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP RS 1983-12-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DOXY 100(TM) 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 51662-1402-1 DOXY 100(TM) DOXYCYCLINE 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 4 51662-1402-2 DOXY 100(TM) DOXYCYCLINE 1 in 1 POUCH INJECTION, POWDER, LYOPHILIZED, 1 4 51662-1402-2 DOXY 100(TM) DOXYCYCLINE 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 4 51662-1402-3 DOXY 100(TM) DOXYCYCLINE 10 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1402 DOXY 100(TM) DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 4 Current NDC, Legacy NDC, 4 package rows 20240201_9454f948-584f-59de-e053-2a95a90a9f01.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DOXY 100(TM) DOXYCYCLINE DOXY 100(TM) DOXYCYCLINE HF Acquisition Co LLC, DBA HealthFirst 9454f948-584f-59de-e053-2a95a90a9f01 2024-01-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062475 application number: ANDA062475 ndc (product): 51662-1402 Doxy 100 DOXYCYCLINE Fresenius Kabi USA, LLC b256babb-1bba-4b0c-8837-d13ba3af7659 2021-02-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062475 application number: ANDA062475 Doxy 100 DOXYCYCLINE Fresenius Kabi USA, LLC a7b754e2-a028-469d-ba95-8412ef03ab0a 2021-02-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062475 application number: ANDA062475 Doxy 100 DOXYCYCLINE Fresenius Kabi USA, LLC b0894010-39bd-459f-8563-cf83343105ee 2020-06-04 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062475 application number: ANDA062475
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 51662-1402-1 51662140201 10 mL in 1 VIAL (51662-1402-1) 10 ml 2019-10-07 0000-00-00 No No Current 51662-1402-2 51662140202 1 in 1 POUCH Historical 51662-1402-3 51662140203 10 POUCH in 1 BOX (51662-1402-3) / 1 VIAL in 1 POUCH (51662-1402-2) / 10 mL in 1 VIAL 10 pouch 2022-03-16 0000-00-00 No No Current