Home NDC 70436-032 doxycycline hyclate
Product NDC 70436-032
11-digit product format 704360032
Labeler code 70436
Product ID 70436-032_3c36af25-61de-f322-e063-6394a90ab704
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxycycline hyclate
Dosage form POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA217685
Marketing category ANDA
Marketing start 2024-07-22
Substance DOXYCYCLINE ANHYDROUS
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 A217685-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 A217685-002 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21
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.
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 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base doxycycline hyclate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE ANHYDROUS 100 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 334895S862 Internal UNII 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 70436-032-35 doxycycline hyclate 10 mL in 1 VIAL, SINGLE-DOSE POWDER, FOR SOLUTION 10 5 70436-032-82 doxycycline hyclate 10 in 1 CARTON POWDER, FOR SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-032 DOXYCYCLINE HYCLATE POWDER, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] 2 Current NDC, 2 package rows 20240722_f31e69fc-e513-40e4-91b5-22ccf1ed9437.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70436-032-35 70436003235 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 70436-032-82 70436003282 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-032-82) / 10 mL in 1 VIAL, SINGLE-DOSE (70436-032-35) 2024-07-22 No No Current