Valacyclovir hydrochloride
- Product NDC
- 69097-154
- Requested package NDC
- 69097-154-02
- 11-digit product format
- 690970154
- Labeler code
- 69097
- Product ID
- 69097-154_b56b9a21-be9f-4ba6-84ca-b08de39b9f3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valacyclovir hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA077135
- Marketing category
- ANDA
- Marketing start
- 2010-05-24
- Marketing end
- 0000-00-00
- Substance
- VALACYCLOVIR HYDROCHLORIDE
- Active strength
- 1000 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 package | package | 69097-154 | 69097-154-02 | D | Discontinued by firm | 2026-08-11 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077135-001 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | ||
| A077135-002 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | 2010-05-24 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | 2010-05-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077135-001 | 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 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077135-001 | VALACYCLOVIR HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2010-05-24 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077135-002 | VALACYCLOVIR HYDROCHLORIDE | EQ 1GM BASE | TABLET / ORAL | AB | 2010-05-24 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077135-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077135-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077135-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077135-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077135-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077135-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077135-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077135-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077135-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077135-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077135-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077135-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077135-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077135-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077135-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A077135-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077135-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A077135-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077135-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A077135-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077135-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077135-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077135-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077135-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077135-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077135-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077135-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077135-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077135-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A077135-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A077135-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A077135-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077135-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077135-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077135-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077135-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077135-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077135-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077135-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077135-002 | AB | 1 | 3f0d92c62455… |
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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69097-154-02 | EA - Each | 69097-154 | 39a9950e-3db7-4058-bd33-bb9d1d456230 | 1 | 2015-02-02 |
| 69097-154-05 | EA - Each | 69097-154 | 069d93e3-97c0-463d-ab94-631ec71de104 | 1 | 2015-02-02 |
| 69097-154-12 | EA - Each | 69097-154 | 8a1da214-9843-44ee-b5f4-912c42c2ab85 | 1 | 2015-02-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313564 | valACYclovir 1 GM Oral Tablet | PSN | 9613129c-2c1e-dbfd-e053-2a95a90af0cb | 9 |
| 313564 | valacyclovir 1000 MG Oral Tablet | SCD | 9613129c-2c1e-dbfd-e053-2a95a90af0cb | 9 |
| 313564 | valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet | SY | 9613129c-2c1e-dbfd-e053-2a95a90af0cb | 9 |
| 313564 | valacyclovir 1 GM Oral Tablet | SY | 9613129c-2c1e-dbfd-e053-2a95a90af0cb | 9 |
| 313564 | valACYclovir 1 GM Oral Tablet | PSN | 3331ed10-1d2b-4c88-ad2d-881f7f476198 | 3 |
| 313565 | valACYclovir 500 MG Oral Tablet | PSN | 3331ed10-1d2b-4c88-ad2d-881f7f476198 | 3 |
| 313564 | valacyclovir 1000 MG Oral Tablet | SCD | 3331ed10-1d2b-4c88-ad2d-881f7f476198 | 3 |
| 313565 | valacyclovir 500 MG Oral Tablet | SCD | 3331ed10-1d2b-4c88-ad2d-881f7f476198 | 3 |
| 313564 | valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet | SY | 3331ed10-1d2b-4c88-ad2d-881f7f476198 | 3 |
| 313565 | valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet | SY | 3331ed10-1d2b-4c88-ad2d-881f7f476198 | 3 |
| 313564 | valacyclovir 1 GM Oral Tablet | SY | 3331ed10-1d2b-4c88-ad2d-881f7f476198 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69097-154-02 | 69097015402 | 30 TABLET in 1 BOTTLE (69097-154-02) | 30 tablet | 2010-05-24 | 0000-00-00 | No | No | Current |