Home NDC 0143-9381 Doxycycline
Product NDC 0143-9381
11-digit product format 001439381
Labeler code 0143
Product ID 0143-9381_fa074f92-7cf9-4290-8cf7-7a2b94447cf3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA062992
Marketing category ANDA
Marketing start 2021-05-17
Substance DOXYCYCLINE HYCLATE
Active strength 100 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 42 .
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 A062992-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 A062992-002 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16
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 · 84 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 2026-08-18 06:07:40 2026-07 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION 1989-02-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION 1989-02-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062992-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062992-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 1989-02-16 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 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/1
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 0143-9381-01 Doxycycline 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 4 0143-9381-10 Doxycycline 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9381 DOXYCYCLINE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250502_2aa835bd-6fac-46b8-9716-9622fb550c8f.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 Marketing end Sample Exclude flag Status 0143-9381-01 00143938101 1 in 1 VIAL Historical 0143-9381-10 00143938110 10 VIAL in 1 CARTON (0143-9381-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9381-01) 10 vial 2021-05-17 0000-00-00 No No Current