Home NDC 53002-0083 Acyclovir
Product NDC 53002-0083
11-digit product format 530020083
Labeler code 53002
Product ID 53002-0083_c7c01967-27fa-42cb-9243-7d263778edfe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA210401
Marketing category ANDA
Marketing start 2018-05-04
Marketing end 0000-00-00
Substance ACYCLOVIR
Active strength 400 mg/1
Pharmacologic classes DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 53002-0083-1 2025-01-30 C162847 48780-1 2cef2736-8c92-d83d-e063-dadaa90ab31f ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg 53002-0083-2 2025-01-30 C162847 48780-1 2cef2736-8c92-d83d-e063-dadaa90ab31f ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg 53002-0083-3 2025-01-30 C162847 48780-1 2cef2736-8c92-d83d-e063-dadaa90ab31f ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg 53002-0083-4 2025-01-30 C162847 48780-1 2cef2736-8c92-d83d-e063-dadaa90ab31f ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg 53002-0083-5 2025-01-30 C162847 48780-1 2cef2736-8c92-d83d-e063-dadaa90ab31f ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg 53002-0083-6 2025-01-30 C162847 48780-1 2cef2736-8c92-d83d-e063-dadaa90ab31f ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg 53002-0083-9 2025-01-30 C162847 48780-1 2cef2736-8c92-d83d-e063-dadaa90ab31f ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-0083 ACYCLOVIR TABLET [RPK PHARMACEUTICALS, INC.] 1 Legacy NDC, 7 package rows 20220331_b28714cf-dfbf-404b-92d5-3c25437d98b6.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 53002-0083-1 53002008301 15 TABLET in 1 BOTTLE (53002-0083-1) 15 tablet 2022-10-01 0000-00-00 No No Current 53002-0083-2 53002008302 20 TABLET in 1 BOTTLE (53002-0083-2) 20 tablet 2022-10-01 0000-00-00 No No Current 53002-0083-3 53002008303 21 TABLET in 1 BOTTLE (53002-0083-3) 21 tablet 2022-10-01 0000-00-00 No No Current 53002-0083-4 53002008304 30 TABLET in 1 BOTTLE (53002-0083-4) 30 tablet 2022-10-01 0000-00-00 No No Current 53002-0083-5 53002008305 35 TABLET in 1 BOTTLE (53002-0083-5) 35 tablet 2022-10-01 0000-00-00 No No Current 53002-0083-6 53002008306 50 TABLET in 1 BOTTLE (53002-0083-6) 50 tablet 2022-10-01 0000-00-00 No No Current 53002-0083-9 53002008309 60 TABLET in 1 BOTTLE (53002-0083-9) 60 tablet 2022-10-01 0000-00-00 No No Current