Home NDC 82644-870 Tetracycline Hydrochloride
Product NDC 82644-870
11-digit product format 826440870
Labeler code 82644
Product ID 82644-870_3d44a562-4fde-4867-90e6-433ea752bb3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tetracycline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pharmaka Generics Inc.
Application ANDA061147
Marketing category ANDA
Marketing start 2024-01-19
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A061147-001 SUMYCIN TETRACYCLINE HYDROCHLORIDE 250MG TABLET / ORAL Approved before 1982 A061147-002 SUMYCIN TETRACYCLINE HYDROCHLORIDE 100MG TABLET / ORAL Approved before 1982 A061147-003 SUMYCIN TETRACYCLINE HYDROCHLORIDE 50MG TABLET / ORAL Approved before 1982 A061147-004 SUMYCIN TETRACYCLINE HYDROCHLORIDE 500MG TABLET / ORAL RS, Approved before 1982
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 5 · 168 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 A061147-001 SUMYCIN 250MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A061147-002 SUMYCIN 100MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A061147-003 SUMYCIN 50MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A061147-004 SUMYCIN 500MG TABLET / ORAL RS, Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A061147-001 SUMYCIN 250MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061147-002 SUMYCIN 100MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061147-003 SUMYCIN 50MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061147-004 SUMYCIN 500MG TABLET / ORAL RS, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061147-001 SUMYCIN 250MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061147-002 SUMYCIN 100MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061147-003 SUMYCIN 50MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061147-004 SUMYCIN 500MG TABLET / ORAL RS, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A061147-001 SUMYCIN 250MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061147-002 SUMYCIN 100MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061147-003 SUMYCIN 50MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061147-004 SUMYCIN 500MG TABLET / ORAL RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061147-001 SUMYCIN 250MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061147-002 SUMYCIN 100MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061147-003 SUMYCIN 50MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061147-004 SUMYCIN 500MG TABLET / ORAL RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061147-001 SUMYCIN 250MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061147-002 SUMYCIN 100MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061147-003 SUMYCIN 50MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061147-004 SUMYCIN 500MG TABLET / ORAL RS, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061147-001 SUMYCIN 250MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061147-002 SUMYCIN 100MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061147-003 SUMYCIN 50MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061147-004 SUMYCIN 500MG TABLET / ORAL RS, Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061147-001 SUMYCIN 250MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061147-002 SUMYCIN 100MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061147-003 SUMYCIN 50MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061147-004 SUMYCIN 500MG TABLET / ORAL RS, Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061147-001 SUMYCIN 250MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061147-002 SUMYCIN 100MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061147-003 SUMYCIN 50MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061147-004 SUMYCIN 500MG TABLET / ORAL RS, Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061147-001 SUMYCIN 250MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061147-002 SUMYCIN 100MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061147-003 SUMYCIN 50MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061147-004 SUMYCIN 500MG TABLET / ORAL RS, Approved before 1982 d8e5a09893c0…
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313252 Internal RxNorm lookup 313254 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 82644-870-60 Tetracycline Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82644-870 TETRACYCLINE HYDROCHLORIDE TABLET, FILM COATED [PHARMAKA GENERICS INC.] 1 Current NDC, 1 package rows 20240120_c522c860-84ce-4c61-ab72-077de73195df.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 Marketing start Sample Exclude flag Status 82644-870-60 82644087060 60 TABLET, FILM COATED in 1 BOTTLE (82644-870-60) 2024-01-19 No No Current