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acyclovir

Acyclovir Capsules, USP Rx only

Approved
Approval ID

c818e86c-a4d0-48cd-a888-fa1ee9e2aa19

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 22, 2025

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

acyclovir

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71335-2261
Application NumberANDA204313
Product Classification
M
Marketing Category
C73584
G
Generic Name
acyclovir
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2025
FDA Product Classification

INGREDIENTS (9)

SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ACYCLOVIRActive
Quantity: 200 mg in 1 1
Code: X4HES1O11F
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/22/2025

Acyclovir 200mg Capsule

Label

DESCRIPTION SECTION

LOINC: 34089-3Updated: 10/4/2019

DESCRIPTION

Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules are formulation for oral administration.

Acyclovir is a white or almost white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225.20. It is soluble in diluted hydrochloric acid; slightly soluble in water and insoluble in alcohol. The pka’s of acyclovir are 2.27 and 9.25.

The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula:

![figure](/dailymed/image.cfm?name=3f2172cb- ac55-4885-924b-b2b0a090bb46-01.jpg&id=898955)

Each acyclovir capsule intended for oral administration contains 200 mg of acyclovir. In addition, each capsule contains the following inactive ingredients: corn starch, FD & C blue # 1, FD & C red # 3, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate and titanium dioxide. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 9/22/2025

HOW SUPPLIED

Acyclovir Capsules USP, 200 mg are white to off-white powder filled in size "1" empty hard gelatin capsules with blue opaque colored cap imprinted with '668' in black ink and white opaque colored body and are supplied as follows:

NDC: 71335-2261-1: 30 Capsules in a BOTTLE

NDC: 71335-2261-2: 25 Capsules in a BOTTLE

NDC: 71335-2261-3: 35 Capsules in a BOTTLE

NDC: 71335-2261-4: 50 Capsules in a BOTTLE

NDC: 71335-2261-5: 100 Capsules in a BOTTLE

NDC: 71335-2261-6: 40 Capsules in a BOTTLE

NDC: 71335-2261-7: 60 Capsules in a BOTTLE

NDC: 71335-2261-8: 120 Capsules in a BOTTLE

NDC: 71335-2261-9: 20 Capsules in a BOTTLE

NDC: 71335-2261-0: 90 Capsules in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

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acyclovir - FDA Drug Approval Details