FDA.reportPublic FDA data

Acyclovir

Product NDC
52959-544
11-digit product format
529590544
Labeler code
52959
Product ID
52959-544_5e218603-4810-d859-e053-2991aa0a7241
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company Inc.
Application
ANDA074556
Marketing category
ANDA
Marketing start
2017-01-03
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-544-012020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241
52959-544-102020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241
52959-544-122020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241
52959-544-152020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241
52959-544-202020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241
52959-544-212020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241
52959-544-252020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241
52959-544-302020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241
52959-544-352020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241
52959-544-402020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241
52959-544-452020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241
52959-544-502020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241
52959-544-602020-01-31C16284748780-19d75b9d0-426d-f424-e053-dadaa90a57ce5e218603-480f-d859-e053-2991aa0a7241

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-544-01Acyclovir100 in 1 CONTAINERTABLET1001
52959-544-10Acyclovir10 in 1 CONTAINERTABLET101
52959-544-12Acyclovir12 in 1 CONTAINERTABLET121
52959-544-15Acyclovir15 in 1 CONTAINERTABLET151
52959-544-20Acyclovir20 in 1 CONTAINERTABLET201
52959-544-21Acyclovir21 in 1 CONTAINERTABLET211
52959-544-25Acyclovir25 in 1 CONTAINERTABLET251
52959-544-30Acyclovir30 in 1 CONTAINERTABLET301
52959-544-35Acyclovir35 in 1 CONTAINERTABLET351
52959-544-40Acyclovir40 in 1 CONTAINERTABLET401
52959-544-45Acyclovir45 in 1 CONTAINERTABLET451
52959-544-50Acyclovir50 in 1 CONTAINERTABLET501
52959-544-60Acyclovir60 in 1 CONTAINERTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-544-01EA - Each52959-54400b58407-d9cd-41e1-ac4a-2ee55a11882212017-12-14
52959-544-10EA - Each52959-5442db061ab-86f6-41ed-9b33-64027096ab7512017-12-14
52959-544-12EA - Each52959-544924bfa70-e97f-426d-b9a0-ca23c4c34aee12017-12-14
52959-544-15EA - Each52959-5446239adba-b9a8-403b-89ce-466760c151ea12017-12-14
52959-544-21EA - Each52959-54465e22eaa-17eb-407f-ab3a-aaa21d0b0c4812017-12-14
52959-544-25EA - Each52959-544ca243df1-f175-42e1-8f53-82f76c58ff4e12017-12-14
52959-544-30EA - Each52959-54417fe7787-7936-4eb0-af87-e3e0d99786b312017-12-14
52959-544-40EA - Each52959-5447b68e921-8b14-4b20-82cc-ccf897f7c04c12017-12-14
52959-544-50EA - Each52959-544a5177ec0-ee11-4169-9ca8-5c067b4f36ae12017-12-14
52959-544-60EA - Each52959-544b607ff1d-2ec3-48c8-921a-8eed6bee8fe612017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-544ACYCLOVIR TABLET [H.J. HARKINS COMPANY INC.]1Legacy NDC, 13 package rows20171122_5e218603-480f-d859-e053-2991aa0a7241.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN5e218603-480f-d859-e053-2991aa0a72411
197311acyclovir 400 MG Oral TabletSCD5e218603-480f-d859-e053-2991aa0a72411
197311acycycloguanosine 400 MG Oral TabletSY5e218603-480f-d859-e053-2991aa0a72411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-544-0152959054401100 in 1 CONTAINERHistorical
52959-544-105295905441010 in 1 CONTAINERHistorical
52959-544-125295905441212 in 1 CONTAINERHistorical
52959-544-155295905441515 in 1 CONTAINERHistorical
52959-544-205295905442020 in 1 CONTAINERHistorical
52959-544-215295905442121 in 1 CONTAINERHistorical
52959-544-255295905442525 in 1 CONTAINERHistorical
52959-544-305295905443030 in 1 CONTAINERHistorical
52959-544-355295905443535 in 1 CONTAINERHistorical
52959-544-405295905444040 in 1 CONTAINERHistorical
52959-544-455295905444545 in 1 CONTAINERHistorical
52959-544-505295905445050 in 1 CONTAINERHistorical
52959-544-605295905446060 in 1 CONTAINERHistorical