Valacyclovir Hydrochloride
- Product NDC
- 68071-2749
- 11-digit product format
- 680712749
- Labeler code
- 68071
- Product ID
- 68071-2749_e07f727b-f7b2-09dc-e053-2a95a90a3d0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valacyclovir Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA090682
- Marketing category
- ANDA
- Marketing start
- 2010-05-24
- Marketing end
- 0000-00-00
- Substance
- VALACYCLOVIR HYDROCHLORIDE
- Active strength
- 500 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
- 2023-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68071-2749 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 68071-2749 | 68071-2749-3 | I | Inactivated by FDA | 2026-10-05 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-2749-3 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-2749-3 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-2749-3 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-2749-3 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-2749-3 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-2749-3 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-2749-3 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-2749-3 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-2749-3 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090682-001 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | |
| A090682-002 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090682-001 | AB |
| A090682-002 | 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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090682-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090682-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090682-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090682-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090682-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090682-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090682-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090682-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090682-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090682-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090682-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090682-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090682-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090682-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090682-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090682-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090682-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090682-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090682-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090682-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090682-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090682-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090682-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090682-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090682-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090682-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090682-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090682-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090682-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090682-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090682-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090682-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090682-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090682-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090682-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090682-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090682-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090682-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090682-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090682-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090682-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090682-002 | AB | 1 | 74a2ff9319b5… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-2749-3 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a810-d83d-e063-dadaa90ab31f | These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2749-3 | Valacyclovir Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2749 | VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 1 | Legacy NDC, 1 package rows | 20220603_e07f7cd0-53b5-9065-e053-2a95a90a0bc2.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Cardinal Health 107, LLC | 72300f70-57fd-42a8-a2dc-4cf95a1ce805 | 2026-08-13 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | REMEDYREPACK INC. | de96c14b-cd74-46dd-bcce-d1fa640a6037 | 2026-08-06 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Redpharm Drug | 57e5cc11-f3cb-6266-e063-6394a90afc47 | 2026-07-31 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | REMEDYREPACK INC. | 740bbed7-b2dd-4ad9-99e0-03a9f1d61e3f | 2026-07-22 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Bryant Ranch Prepack | a56f37e1-dcc2-4fb1-ae39-bb20b9b7a3d3 | 2026-06-16 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 275c0198-10a5-139e-e063-6394a90a72be | 2026-06-04 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Bryant Ranch Prepack | 93dccd99-d28b-4c47-872c-c3c0001b8a7f | 2026-06-04 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1a888812-2867-4dd3-b56e-2d98da837d1f | 2026-05-12 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | NorthStar Rx LLC | 4acf51de-26f7-42b2-8acc-61b800627ef3 | 2026-05-12 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Sportpharm LLC | 7681a6f4-a6e7-4277-adbd-38837d5ead6b | 2026-04-24 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | A-S Medication Solutions | 8c0be4f6-2d11-41d4-8f57-4f8db9da60b2 | 2026-03-24 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Major Pharmaceuticals | fd982aee-d503-47b3-8d3d-42e9a8690457 | 2026-03-24 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | A-S Medication Solutions | 87ec59e3-c06a-4ca7-bc65-5b251263ab3b | 2026-03-17 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | A-S Medication Solutions | df34e11d-5f2c-4755-b84b-b95d1d7b73f0 | 2026-03-17 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 8d1645c0-fd03-4992-9372-98026a26b3af | 2026-03-10 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ae8d15a4-1ed5-4e3c-9672-0f4735322a1c | 2026-02-25 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | e300970d-1145-4460-a8c8-f6e1654c2c3d | 2026-02-25 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Sportpharm LLC | 458bb24a-4f97-4003-93cb-356906a432c9 | 2026-02-05 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Northwind Health Company, LLC | f32d5f04-4198-82a5-e053-2995a90a1841 | 2026-01-01 | Warnings, Adverse reactions | 090682 ANDA090682 |
| Valacyclovir Hydrochloride | VALACYCLOVIR HYDROCHLORIDE | Northwind Health Company, LLC | f98aea50-e4d9-c0cc-e053-6294a90a811c | 2026-01-01 | Warnings, Adverse reactions | 090682 ANDA090682 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313565 | valACYclovir 500 MG Oral Tablet | PSN | e07f7cd0-53b5-9065-e053-2a95a90a0bc2 | 1 |
| 313565 | valacyclovir 500 MG Oral Tablet | SCD | e07f7cd0-53b5-9065-e053-2a95a90a0bc2 | 1 |
| 313565 | valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet | SY | e07f7cd0-53b5-9065-e053-2a95a90a0bc2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-2749-3 | 68071274903 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-2749-3) | 2022-06-02 | 0000-00-00 | No | No | Current |