Valacyclovir hydrochloride
- Product NDC
- 69097-153
- 11-digit product format
- 690970153
- Labeler code
- 69097
- Product ID
- 69097-153_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
- 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
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 |
|---|---|---|---|---|---|
| 69097-153-02 | EA - Each | 69097-153 | 6925b923-9cbb-4ea5-b0fe-fb98d7151c2a | 1 | 2015-02-02 |
| 69097-153-05 | EA - Each | 69097-153 | eb9ce29c-624b-41e7-a9ca-673681431d32 | 1 | 2015-02-02 |
| 69097-153-12 | EA - Each | 69097-153 | 5bc696e0-8d90-40e5-bba9-755c706b3ae9 | 1 | 2015-02-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313565 | valACYclovir 500 MG Oral Tablet | PSN | c153155b-69dc-41b7-91d2-0949ec496174 | 8 |
| 313565 | valacyclovir 500 MG Oral Tablet | SCD | c153155b-69dc-41b7-91d2-0949ec496174 | 8 |
| 313565 | valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet | SY | c153155b-69dc-41b7-91d2-0949ec496174 | 8 |
| 313565 | valACYclovir 500 MG Oral Tablet | PSN | 49db4bcd-8b5a-048d-e054-00144ff88e88 | 5 |
| 313565 | valacyclovir 500 MG Oral Tablet | SCD | 49db4bcd-8b5a-048d-e054-00144ff88e88 | 5 |
| 313565 | valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet | SY | 49db4bcd-8b5a-048d-e054-00144ff88e88 | 5 |
| 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 |
| 313565 | valACYclovir 500 MG Oral Tablet | PSN | 8b9c314b-5c34-3bd7-e053-2a95a90a573f | 2 |
| 313565 | valacyclovir 500 MG Oral Tablet | SCD | 8b9c314b-5c34-3bd7-e053-2a95a90a573f | 2 |
| 313565 | valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet | SY | 8b9c314b-5c34-3bd7-e053-2a95a90a573f | 2 |
| 313565 | valACYclovir 500 MG Oral Tablet | PSN | 874aa629-1332-0c30-e053-2a95a90ac888 | 1 |
| 313565 | valacyclovir 500 MG Oral Tablet | SCD | 874aa629-1332-0c30-e053-2a95a90ac888 | 1 |
| 313565 | valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet | SY | 874aa629-1332-0c30-e053-2a95a90ac888 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69097-153-02 | 69097015302 | 30 TABLET in 1 BOTTLE (69097-153-02) | 30 tablet | 2010-05-24 | 0000-00-00 | No | No | Current |
| 69097-153-05 | 69097015305 | 90 TABLET in 1 BOTTLE (69097-153-05) | 90 tablet | 2010-05-24 | 0000-00-00 | No | No | Current |
| 69097-153-12 | 69097015312 | 500 TABLET in 1 BOTTLE (69097-153-12) | 500 tablet | 2010-05-24 | 0000-00-00 | No | No | Current |