Acyclovir

Product NDC: 62135-803
11-digit product format: 621350803
Labeler code: 62135
Product ID: 62135-803_463b5fcf-cfc0-be52-e063-6394a90aa459
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acyclovir
Dosage form: SUSPENSION
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA212718
Marketing category: ANDA
Marketing start: 2020-04-23
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: 2026-12-31
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
A212718-001	ACYCLOVIR	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB		2020-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212718-001	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.

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	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212718-001	ACYCLOVIR	200MG/5ML	SUSPENSION / ORAL	AB	2020-04-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212718-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212718-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212718-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212718-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212718-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212718-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212718-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212718-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212718-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212718-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212718-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212718-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212718-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212718-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212718-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212718-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212718-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212718-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212718-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212718-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212718-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212718-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212718-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212718-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212718-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212718-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212718-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212718-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212718-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212718-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212718-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212718-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212718-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212718-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212718-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212718-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212718-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acyclovir
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACYCLOVIR	200 mg/5mL

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
307730	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
7d2a75a5-233f-46dd-9cb0-3918ea53e554	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	SPL version
62135-803-05	Acyclovir	5 mL in 1 CUP	SUSPENSION	5	4
62135-803-20	Acyclovir	20 mL in 1 CUP	SUSPENSION	20	4
62135-803-23	Acyclovir	2 in 1 BOX	SUSPENSION	2	4
62135-803-23	Acyclovir	10 in 1 TRAY	SUSPENSION	10	4
62135-803-24	Acyclovir	2 in 1 BOX	SUSPENSION	2	4
62135-803-24	Acyclovir	10 in 1 TRAY	SUSPENSION	10	4
62135-803-47	Acyclovir	473 mL in 1 BOTTLE	SUSPENSION	473	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-803-05	ML - Milliliter	62135-803	1868a1b7-fe8d-4fd8-b0aa-00b0c669c51f	1	2025-05-14
62135-803-20	ML - Milliliter	62135-803	5a97b68c-0f0b-48d9-bbe4-fc0b0d5ad757	1	2025-05-14
62135-803-23	ML - Milliliter	62135-803	7fbb532d-1987-4843-9d09-106533b924d1	1	2025-05-14
62135-803-24	ML - Milliliter	62135-803	dba974aa-1176-4710-a577-29de7f345cb4	1	2025-05-14
62135-803-47	ML - Milliliter	62135-803	fa5877b7-06ff-4bab-b71e-cba0d72820f3	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-803	ACYCLOVIR SUSPENSION [CHARTWELL RX, LLC]	2	Current NDC, 7 package rows	20250323_7d2a75a5-233f-46dd-9cb0-3918ea53e554.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acyclovir	ACYCLOVIR	Chartwell Governmental & Specialty RX, LLC.	2757bb30-3374-4e1b-b496-14874f7ec623	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212718 application number: ANDA212718
Acyclovir	ACYCLOVIR	Chartwell RX, LLC	7d2a75a5-233f-46dd-9cb0-3918ea53e554	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212718 application number: ANDA212718 ndc (product): 62135-803

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
307730	acyclovir 200 MG in 5 mL Oral Suspension	PSN	7d2a75a5-233f-46dd-9cb0-3918ea53e554	4
307730	acyclovir 40 MG/ML Oral Suspension	SCD	7d2a75a5-233f-46dd-9cb0-3918ea53e554	4
307730	acyclovir 200 MG per 5 ML Oral Suspension	SY	7d2a75a5-233f-46dd-9cb0-3918ea53e554	4
307730	acycycloguanosine 40 MG/ML Oral Suspension	SY	7d2a75a5-233f-46dd-9cb0-3918ea53e554	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-803-05	62135080305	5 mL in 1 CUP	5 ml				Historical
62135-803-20	62135080320	20 mL in 1 CUP	20 ml				Historical
62135-803-23	62135080323	2 TRAY in 1 BOX (62135-803-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-803-20)	2 tray	2025-03-20	No	No	Current
62135-803-24	62135080324	2 TRAY in 1 BOX (62135-803-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-803-05)	2 tray	2025-03-20	No	No	Current
62135-803-47	62135080347	473 mL in 1 BOTTLE (62135-803-47)	473 ml	2023-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acyclovir Oral Suspension, USP Rx only	Chartwell RX, LLC	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	4