Home NDC 64679-923 ENALAPRIL MALEATE
Product NDC 64679-923
11-digit product format 646790923
Labeler code 64679
Product ID 64679-923_d28c717f-3eff-ff87-e053-2995a90a3b47
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ENALAPRIL MALEATE
Dosage form TABLET
Route ORAL
Labeler Wockhardt USA LLC.
Application ANDA075483
Marketing category ANDA
Marketing start 2009-12-11
Marketing end 0000-00-00
Substance ENALAPRIL MALEATE
Active strength 3 mg/1
Pharmacologic classes Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag No
Listing certified through 2022-12-31
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 2 · 105 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075483-001 ENALAPRIL MALEATE ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 A075483-002 ENALAPRIL MALEATE ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 A075483-003 ENALAPRIL MALEATE ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 A075483-004 ENALAPRIL MALEATE ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 172 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 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64679-923-01 2025-12-23 ENALAPRIL MALEATE TABLETS, USP 64679-923-02 2025-12-23 ENALAPRIL MALEATE TABLETS, USP 64679-923-03 2025-12-23 ENALAPRIL MALEATE TABLETS, USP 64679-923-07 2025-12-23 ENALAPRIL MALEATE TABLETS, USP 64679-923-09 2025-12-23 ENALAPRIL MALEATE TABLETS, USP 64679-923-10 2025-12-23 ENALAPRIL MALEATE TABLETS, USP 64679-923-01 2023-01-30 ENALAPRIL MALEATE TABLETS, USP 64679-923-02 2023-01-30 ENALAPRIL MALEATE TABLETS, USP 64679-923-03 2023-01-30 ENALAPRIL MALEATE TABLETS, USP 64679-923-07 2023-01-30 ENALAPRIL MALEATE TABLETS, USP 64679-923-09 2023-01-30 ENALAPRIL MALEATE TABLETS, USP 64679-923-10 2023-01-30 ENALAPRIL MALEATE TABLETS, USP
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ENALAPRIL MALEATE ACTIVE INGREDIENT 9O25354EPJ ENALAPRIL MALEATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 15 ENALAPRILAT ANHYDROUS ACTIVE MOIETY Q508Q118JM ENALAPRIL MALEATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 15 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ENALAPRIL MALEATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ENALAPRIL MALEATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ENALAPRIL MALEATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 15 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ENALAPRIL MALEATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 15 TALC INACTIVE INGREDIENT 7SEV7J4R1U ENALAPRIL MALEATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 15 ENALAPRIL MALEATE ACTIVE INGREDIENT 9O25354EPJ ENALAPRIL MALEATE TABLET [MAJOR PHARMACEUTICALS] 5 ENALAPRILAT ACTIVE MOIETY GV0O7ES0R3 ENALAPRIL MALEATE TABLET [MAJOR PHARMACEUTICALS] 5 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ENALAPRIL MALEATE TABLET [MAJOR PHARMACEUTICALS] 5 ENALAPRIL MALEATE ACTIVE INGREDIENT 9O25354EPJ ENALAPRIL MALEATE TABLET [WOCKHARDT USA LLC.] 4 ENALAPRILAT ANHYDROUS ACTIVE MOIETY Q508Q118JM ENALAPRIL MALEATE TABLET [WOCKHARDT USA LLC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ENALAPRIL MALEATE TABLET [WOCKHARDT USA LLC.] 4 BROWN IRON OXIDE INACTIVE INGREDIENT 1N032N7MFO ENALAPRIL MALEATE TABLET [WOCKHARDT USA LLC.] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ENALAPRIL MALEATE TABLET [WOCKHARDT USA LLC.] 4 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 ENALAPRIL MALEATE TABLET [WOCKHARDT USA LLC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ENALAPRIL MALEATE TABLET [WOCKHARDT USA LLC.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ENALAPRIL MALEATE TABLET [WOCKHARDT USA LLC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U ENALAPRIL MALEATE TABLET [WOCKHARDT USA LLC.] 4 ENALAPRIL MALEATE ACTIVE INGREDIENT 9O25354EPJ ENALAPRIL MALEATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 ENALAPRIL MALEATE ACTIVE INGREDIENT 9O25354EPJ ENALAPRIL MALEATE TABLET [UNIT DOSE SERVICES] 2 ENALAPRIL ACTIVE MOIETY 69PN84IO1A ENALAPRIL MALEATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 ENALAPRILAT ANHYDROUS ACTIVE MOIETY Q508Q118JM ENALAPRIL MALEATE TABLET [UNIT DOSE SERVICES] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ENALAPRIL MALEATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ENALAPRIL MALEATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ENALAPRIL MALEATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ENALAPRIL MALEATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U ENALAPRIL MALEATE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 Enalapril Maleate ACTIVE INGREDIENT 9O25354EPJ ENALAPRIL MALEATE TABLET [MED HEALTH PHARMA, LLC] 1 ENALAPRIL MALEATE ACTIVE INGREDIENT 9O25354EPJ ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Enalapril ACTIVE MOIETY 69PN84IO1A ENALAPRIL MALEATE TABLET [MED HEALTH PHARMA, LLC] 1 ENALAPRIL ACTIVE MOIETY 69PN84IO1A ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ENALAPRIL MALEATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64679-923 ENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [WOCKHARDT USA LLC.] 7 Legacy NDC 20211208_d41d6d19-086c-4e17-814c-6fd6f3e81e24.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64679-923-01 64679092301 90 TABLET in 1 BOTTLE (64679-923-01) 90 tablet 2009-12-11 0000-00-00 No No Current 64679-923-02 64679092302 100 TABLET in 1 BOTTLE (64679-923-02) 100 tablet 2009-12-11 0000-00-00 No No Current 64679-923-03 64679092303 1000 TABLET in 1 BOTTLE (64679-923-03) 1000 tablet 2009-12-11 0000-00-00 No No Current 64679-923-07 64679092307 10 BLISTER PACK in 1 CARTON (64679-923-07) > 10 TABLET in 1 BLISTER PACK 10 blister pack 2009-12-11 0000-00-00 No No Current 64679-923-09 64679092309 40000 TABLET in 1 DRUM (64679-923-09) 40000 tablet 2009-12-11 0000-00-00 No No Current 64679-923-10 64679092310 8000 TABLET in 1 DRUM (64679-923-10) 8000 tablet 2009-12-11 0000-00-00 No No Current