Home NDC 70436-032 doxycycline hyclate
Product NDC 70436-032
11-digit product format 704360032
Labeler code 70436
Product ID 70436-032_5d746365-9e51-60e4-e063-6294a90a1f6c
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 2026-10-15 13:18:30 2026-09 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217685-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217685-002 DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL INJECTABLE / INJECTION AP 2024-06-21 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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
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