Acyclovir

Product NDC: 71921-146
11-digit product format: 719210146
Labeler code: 71921
Product ID: 71921-146_3df7fa38-a869-45fb-98a3-81c5a2527d62
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: CAPSULE
Route: ORAL
Labeler: Florida Pharmaceutical Products, LLC
Application: ANDA075090
Marketing category: ANDA
Marketing start: 2026-02-18
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: 2027-12-31
Current FDA listing: Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075090-001	ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE / ORAL	AB		1999-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075090-001	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075090-001	ACYCLOVIR	200MG	CAPSULE / ORAL	AB	1999-01-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075090-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075090-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075090-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075090-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075090-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075090-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075090-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075090-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075090-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075090-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075090-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075090-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075090-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075090-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075090-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075090-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075090-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075090-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075090-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075090-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075090-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075090-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075090-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075090-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075090-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075090-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075090-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075090-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075090-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075090-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075090-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075090-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075090-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075090-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075090-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075090-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075090-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075090-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075090-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075090-001	AB	1	`cb3db0bc1861…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Florida Pharmaceutical Products, LLC	3df7fa38-a869-45fb-98a3-81c5a2527d62	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090 ndc (product): 71921-146
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	f87c2c1e-568f-49e1-979e-fce80086fe08	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090
Acyclovir	ACYCLOVIR	A-S Medication Solutions	6e813b35-4ead-42d6-bc51-9d7caf1db1ef	2024-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090
Acyclovir	ACYCLOVIR	Bryant Ranch Prepack	e8433261-07f1-448b-aaf4-631414598c08	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090
Acyclovir	ACYCLOVIR	Quinn Pharmaceuticals	9ad711e4-003d-4b58-8177-32928bc42aa9	2022-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090
Acyclovir	ACYCLOVIR	Proficient Rx LP	6714cfd9-97d3-4290-b618-54594d89cf4e	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075090 application number: ANDA075090

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACYCLOVIR	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X4HES1O11F	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197310	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3df7fa38-a869-45fb-98a3-81c5a2527d62	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33190c02-82e1-0a4d-d716-9ccd23588463	Product name	5	20250225
c367d1da-5a72-8966-6d11-1eb9a73ae758	Product name	3	20231115
5518bf13-db2f-2e9c-3679-e70ecf03752c	Product name	9	20210614
27897900-0e40-497b-97e1-88057e68fe6c	Product name	4	20200710
ca834e59-e669-229c-9288-0ccb76dc373e	Product name	9	20200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28	Product name	1	20190702
fb15b394-3715-4c87-a447-421489aa8739	Product name	3	20170727
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71921-146-01	Acyclovir	100 in 1 BOTTLE	CAPSULE	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71921-146-01	EA - Each	71921-146	9c50c833-6a21-49f4-b41b-fd98f8eafb07	1	2026-03-17

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X4HES1O11F	ACYCLOVIR	59277-89-3	ACYCLOVIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197310	acyclovir 200 MG Oral Capsule	PSN	3df7fa38-a869-45fb-98a3-81c5a2527d62	1
197310	acyclovir 200 MG Oral Capsule	SCD	3df7fa38-a869-45fb-98a3-81c5a2527d62	1
197310	acycycloguanosine 200 MG Oral Capsule	SY	3df7fa38-a869-45fb-98a3-81c5a2527d62	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71921-146-01	71921014601	100 CAPSULE in 1 BOTTLE (71921-146-01)	100 capsule	2026-02-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACYCLOVIR- acyclovir capsule	Florida Pharmaceutical Products, LLC \| Contract Pharmacal Corp.	2026-02-18	Human Prescription Drug Label	1