Acyclovir
- Product NDC
- 43353-933
- 11-digit product format
- 433530933
- Labeler code
- 43353
- Product ID
- 43353-933_32129338-bb18-4c4b-80a2-57ee2631feeb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acyclovir
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077309
- Marketing category
- ANDA
- Marketing start
- 2012-09-21
- Marketing end
- 0000-00-00
- Substance
- ACYCLOVIR
- Active strength
- 800 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
- 2019-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43353-933-18 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2356-f424-e053-dadaa90a57ce | ACYCLOVIR TABLETS USP 400 MG AND 800 MG |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43353-933-18 | Acyclovir | 3000 in 1 BOTTLE, PLASTIC | TABLET | 3000 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-933-18 | EA - Each | 43353-933 | 83e9b384-2777-4833-a124-1ec9012cf319 | 1 | 2015-01-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ACYCLOVIR | ACTIVE INGREDIENT | X4HES1O11F | ACYCLOVIR TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| ACYCLOVIR | ACTIVE MOIETY | X4HES1O11F | ACYCLOVIR TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ACYCLOVIR TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ACYCLOVIR TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACYCLOVIR TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ACYCLOVIR TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197313 | acyclovir 800 MG Oral Tablet | PSN | eb863c4f-4e39-4d97-8b7e-30a76fe2119d | 1 |
| 197313 | acyclovir 800 MG Oral Tablet | SCD | eb863c4f-4e39-4d97-8b7e-30a76fe2119d | 1 |
| 197313 | acycycloguanosine 800 MG Oral Tablet | SY | eb863c4f-4e39-4d97-8b7e-30a76fe2119d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 43353-933-18 | 43353093318 | 3000 in 1 BOTTLE, PLASTIC | Historical |