Home NDC 60219-2132 doxycycline hyclate
Product NDC 60219-2132
11-digit product format 602192132
Labeler code 60219
Product ID 60219-2132_2ec0f600-991b-4708-a5f4-08b8e66967f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxycycline hyclate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA216599
Marketing category ANDA
Marketing start 2022-11-09
Marketing end 0000-00-00
Substance DOXYCYCLINE HYCLATE
Active strength 100 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A216599-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24
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 2026-09-14 22:38:34 2026-08 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2022-10-24 3a93d1ddd44b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216599-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2022-10-24 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216599-001 AB 1 3a93d1ddd44b…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60219-2132 DOXYCYCLINE HYCLATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] 7 Legacy NDC 20250403_5882795e-b4c7-4911-8389-1611cf49617b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60219-2132-1 60219213201 100 TABLET, FILM COATED in 1 BOTTLE (60219-2132-1) 2022-11-09 0000-00-00 No No Current 60219-2132-3 60219213203 20 TABLET, FILM COATED in 1 BOTTLE (60219-2132-3) 2022-11-09 0000-00-00 No No Current