Home NDC 68788-8853 Tetracycline Hydrochloride
Product NDC 68788-8853
11-digit product format 687888853
Labeler code 68788
Product ID 68788-8853_4202cbfb-52e9-47f2-bd3a-1003319ca3cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tetracycline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA061837
Marketing category ANDA
Marketing start 2025-03-24
Substance TETRACYCLINE HYDROCHLORIDE
Active strength 500 mg/1
Pharmacologic classes Tetracycline-class Antimicrobial [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 A061837-001 TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 A061837-002 TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982
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 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A061837-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A061837-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB Approved before 1982 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tetracycline Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRACYCLINE HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P6R62377KV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198252 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 68788-8853-3 Tetracycline Hydrochloride 30 in 1 BOTTLE, PLASTIC CAPSULE 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8853 TETRACYCLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.] 1 Current NDC, 1 package rows 20250326_4202cbfb-52e9-47f2-bd3a-1003319ca3cb.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 · 2 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 68788-8853-3 68788885303 30 CAPSULE in 1 BOTTLE, PLASTIC (68788-8853-3) 30 capsule 2025-03-24 No No Current