Home NDC 70121-1616-7 Doxycycline
Product NDC 70121-1616
Requested package NDC 70121-1616-7
11-digit product format 701211616
Labeler code 70121
Product ID 70121-1616_b34b4a98-fd44-4569-a530-0bc4f9046a75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA217487
Marketing category ANDA
Marketing start 2024-12-06
Substance DOXYCYCLINE HYCLATE
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217487-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION 2024-12-04
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 A217487-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION 2024-12-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217487-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION 2024-12-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217487-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION 2024-12-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217487-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION 2024-12-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217487-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION 2024-12-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217487-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION 2024-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217487-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION 2024-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217487-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION 2024-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217487-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217487-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION AP 2024-12-04 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217487-001 DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL INJECTABLE / INJECTION 2024-12-04 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217487-001 AP 1 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217487-001 AP 1 2680178bc6a6…
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
Listing expiration 2027-12-31 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 70121-1616-1 Doxycycline 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 2 70121-1616-7 Doxycycline 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-1616 DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC] 2 Current NDC, 2 package rows 20241207_95ba4d68-2519-4edd-b9a2-5cd2fd00b250.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 Sample Exclude flag Status 70121-1616-7 70121161607 10 VIAL in 1 CARTON (70121-1616-7) / 10 mL in 1 VIAL (70121-1616-1) 10 vial 2024-12-06 No No Current