Acyclovir

Product NDC
63187-154
Requested package NDC
63187-154-90
11-digit product format
631870154
Labeler code
63187
Product ID
63187-154_064a64eb-36f7-401b-86f6-10281d7afd84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074578
Marketing category
ANDA
Marketing start
1997-04-23
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
200 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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63187-15463187-154-90DDiscontinued by firm2026-08-11

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 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-15463187-154-90DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-15463187-154-90DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63187-15463187-154-90IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074578-001ACYCLOVIRACYCLOVIR200MGCAPSULE / ORALAB1997-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074578-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-223f01610625f2…
2019-09-15 20:21 UTC2019-09A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074578-001ACYCLOVIR200MGCAPSULE / ORALAB1997-04-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074578-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074578-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074578-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074578-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074578-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074578-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074578-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074578-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074578-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074578-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074578-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074578-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074578-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074578-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074578-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074578-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074578-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074578-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074578-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074578-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074578-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074578-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074578-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074578-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074578-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074578-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074578-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074578-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074578-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074578-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074578-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074578-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074578-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074578-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074578-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074578-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074578-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074578-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074578-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074578-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE [PROFICIENT RX LP]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE [PROFICIENT RX LP]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHACYCLOVIR CAPSULE [PROFICIENT RX LP]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LACYCLOVIR CAPSULE [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GACYCLOVIR CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACYCLOVIR CAPSULE [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKACYCLOVIR CAPSULE [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACYCLOVIR CAPSULE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LACYCLOVIR CAPSULE [PROFICIENT RX LP]1
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LACYCLOVIR CAPSULE [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACYCLOVIR CAPSULE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JACYCLOVIR CAPSULE [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR CAPSULE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACYCLOVIR CAPSULE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-154ACYCLOVIR CAPSULE [PROFICIENT RX LP]2Legacy NDC20191206_0d088c7f-d806-49da-a34a-46d86e6ca173.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-154-906318701549090 CAPSULE in 1 BOTTLE (63187-154-90) 90 capsule2014-09-010000-00-00NoNoCurrent