Acyclovir suspension

Product NDC
17856-2170
11-digit product format
178562170
Labeler code
17856
Product ID
17856-2170_5105272f-cff9-8898-e063-6394a90aabb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
SUSPENSION
Route
ORAL
Labeler
Atlantic Biologicals Corp.
Application
ANDA217393
Marketing category
ANDA
Marketing start
2023-03-09
Substance
ACYCLOVIR
Active strength
200 mg/5mL
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217393-001ACYCLOVIRACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217393-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-098072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217393-001ACYCLOVIR200MG/5MLSUSPENSION / ORALAB2023-03-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217393-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217393-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217393-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217393-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217393-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217393-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217393-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217393-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217393-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217393-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217393-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217393-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217393-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217393-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217393-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217393-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217393-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217393-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217393-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217393-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217393-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A217393-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A217393-001AB1053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217393-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Acyclovir suspension
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR200 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X4HES1O11FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307730Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5105272f-cff8-8898-e063-6394a90aabb5Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-2170-1Acyclovir suspension72 in 1 CASESUSPENSION721
17856-2170-1Acyclovir suspension5 mL in 1 CUP, UNIT-DOSESUSPENSION51
17856-2170-2Acyclovir suspension10 mL in 1 CUP, UNIT-DOSESUSPENSION101
17856-2170-2Acyclovir suspension72 in 1 CASESUSPENSION721

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acyclovir suspensionACYCLOVIRAtlantic Biologicals Corp.5105272f-cff8-8898-e063-6394a90aabb52026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217393
application number: ANDA217393
ndc (product): 17856-2170
Acyclovir suspensionACYCLOVIRNovadoz Pharmaceuticals LLC3efa1e5e-5a14-4724-a2ca-25702f10faed2023-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217393
application number: ANDA217393

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307730acyclovir 200 MG in 5 mL Oral SuspensionPSN5105272f-cff8-8898-e063-6394a90aabb51
307730acyclovir 40 MG/ML Oral SuspensionSCD5105272f-cff8-8898-e063-6394a90aabb51
307730acyclovir 200 MG per 5 ML Oral SuspensionSY5105272f-cff8-8898-e063-6394a90aabb51
307730acycycloguanosine 40 MG/ML Oral SuspensionSY5105272f-cff8-8898-e063-6394a90aabb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
17856-2170-11785621700172 CUP, UNIT-DOSE in 1 CASE (17856-2170-1) / 5 mL in 1 CUP, UNIT-DOSE2026-05-04NoNoCurrent
17856-2170-21785621700272 CUP, UNIT-DOSE in 1 CASE (17856-2170-2) / 10 mL in 1 CUP, UNIT-DOSE2026-05-04NoNoCurrent