Home NDC 52959-336 Tetracycline Hydrochloride
Product NDC 52959-336
11-digit product format 529590336
Labeler code 52959
Product ID 52959-336_b921807d-5d59-4548-af3c-4152820b1465
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tetracycline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA060704
Marketing category ANDA
Marketing start 2010-03-23
Marketing end 0000-00-00
Substance TETRACYCLINE HYDROCHLORIDE
Active strength 500 mg/1
Pharmacologic classes Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 3 · 168 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A060704-001 TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 A060704-002 TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL 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 3 · 86 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 2026-09-14 22:38:34 2026-08 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52959-336-14 Tetracycline Hydrochloride 14 in 1 BOTTLE, PLASTIC CAPSULE 14 1 52959-336-20 Tetracycline Hydrochloride 20 in 1 BOTTLE, PLASTIC CAPSULE 20 1 52959-336-28 Tetracycline Hydrochloride 28 in 1 BOTTLE, PLASTIC CAPSULE 28 1 52959-336-30 Tetracycline Hydrochloride 30 in 1 BOTTLE, PLASTIC CAPSULE 30 1 52959-336-40 Tetracycline Hydrochloride 40 in 1 BOTTLE, PLASTIC CAPSULE 40 1 52959-336-56 Tetracycline Hydrochloride 56 in 1 BOTTLE, PLASTIC CAPSULE 56 1 52959-336-90 Tetracycline Hydrochloride 90 in 1 BOTTLE, PLASTIC CAPSULE 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TETRACYCLINE HYDROCHLORIDE ACTIVE INGREDIENT P6R62377KV TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 TETRACYCLINE ACTIVE MOIETY F8VB5M810T TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-336 TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.] 1 Legacy NDC, 7 package rows 20120829_54d1720d-edfc-4eb4-8388-f61bd5971336.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-336-14 52959033614 14 in 1 BOTTLE, PLASTIC Historical 52959-336-20 52959033620 20 in 1 BOTTLE, PLASTIC Historical 52959-336-28 52959033628 28 in 1 BOTTLE, PLASTIC Historical 52959-336-30 52959033630 30 in 1 BOTTLE, PLASTIC Historical 52959-336-40 52959033640 40 in 1 BOTTLE, PLASTIC Historical 52959-336-56 52959033656 56 in 1 BOTTLE, PLASTIC Historical 52959-336-90 52959033690 90 in 1 BOTTLE, PLASTIC Historical