Aplisol
- Product NDC
- 42023-104
- 11-digit product format
- 420230104
- Labeler code
- 42023
- Product ID
- 42023-104_a97e057f-6554-4ce2-bc75-3ebc1978e0d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tuberculin Purified Protein Derivative
- Dosage form
- INJECTION
- Route
- INTRADERMAL
- Labeler
- ENDO USA, Inc.
- Application
- BLA103782
- Marketing category
- BLA
- Marketing start
- 2008-04-25
- Substance
- TUBERCULIN PURIFIED PROTEIN DERIVATIVE
- Active strength
- 5 [iU]/.1mL
- Pharmacologic classes
- Antigens, Bacterial [CS], Cell-mediated Immunity [PE], Skin Test Antigen [EPC], Tuberculosis Skin Test [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Aplisol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TUBERCULIN PURIFIED PROTEIN DERIVATIVE | 5 [iU]/.1mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | I7L8FKN87J |
| Rxcui | 313532, 798408 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42023-104-01 | Aplisol | 1 in 1 CARTON | INJECTION | 1 | 11 | |
| 42023-104-01 | Aplisol | 1 mL in 1 VIAL | INJECTION | 1 | 11 | |
| 42023-104-05 | Aplisol | 1 in 1 CARTON | INJECTION | 1 | 11 | |
| 42023-104-05 | Aplisol | 5 mL in 1 VIAL | INJECTION | 5 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42023-104-01 | ML - Milliliter | 42023-104 | 3b808024-0d83-4833-962c-dcdfc205d872 | 1 | 2012-07-24 |
| 42023-104-05 | ML - Milliliter | 42023-104 | 0924da6d-5239-4597-b77f-981c8958f79e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Tuberculin Purified Protein Derivative | ACTIVE INGREDIENT | I7L8FKN87J | APLISOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION [PAR PHARMACEUTICAL, INC.] | 6 | |
| tuberculin Purified Protein Derivative | ACTIVE MOIETY | I7L8FKN87J | APLISOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION [PAR PHARMACEUTICAL, INC.] | 6 | |
| Phenol | INACTIVE INGREDIENT | 339NCG44TV | APLISOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION [PAR PHARMACEUTICAL, INC.] | 6 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | APLISOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION [PAR PHARMACEUTICAL, INC.] | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 798408 | Aplisol 5 UNT in 0.1 ML Injectable Solution | PSN | 9f025046-850f-46c1-bdfd-245032144307 | 16 |
| 313532 | purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable Solution | PSN | 9f025046-850f-46c1-bdfd-245032144307 | 16 |
| 798408 | purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Aplisol] | SBD | 9f025046-850f-46c1-bdfd-245032144307 | 16 |
| 313532 | purified protein derivative of tuberculin 50 UNT/ML Injectable Solution | SCD | 9f025046-850f-46c1-bdfd-245032144307 | 16 |
| 798408 | Aplisol 5 UNT per 0.1 ML Injectable Solution | SY | 9f025046-850f-46c1-bdfd-245032144307 | 16 |
| 798408 | Aplisol 50 UNT/ML Injectable Solution | SY | 9f025046-850f-46c1-bdfd-245032144307 | 16 |
| 313532 | purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable Solution | SY | 9f025046-850f-46c1-bdfd-245032144307 | 16 |
| 798408 | Aplisol 5 UNT in 0.1 ML Injectable Solution | PSN | 1e91a67c-1694-4523-9548-58f7a8871134 | 11 |
| 313532 | purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable Solution | PSN | 1e91a67c-1694-4523-9548-58f7a8871134 | 11 |
| 798408 | purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Aplisol] | SBD | 1e91a67c-1694-4523-9548-58f7a8871134 | 11 |
| 313532 | purified protein derivative of tuberculin 50 UNT/ML Injectable Solution | SCD | 1e91a67c-1694-4523-9548-58f7a8871134 | 11 |
| 798408 | Aplisol 5 UNT per 0.1 ML Injectable Solution | SY | 1e91a67c-1694-4523-9548-58f7a8871134 | 11 |
| 798408 | Aplisol 50 UNT/ML Injectable Solution | SY | 1e91a67c-1694-4523-9548-58f7a8871134 | 11 |
| 313532 | purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable Solution | SY | 1e91a67c-1694-4523-9548-58f7a8871134 | 11 |
| 798408 | Aplisol 5 UNT in 0.1 ML Injectable Solution | PSN | 33ad349a-2969-4591-8c67-4d2a422a5ffb | 3 |
| 313532 | purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable Solution | PSN | 33ad349a-2969-4591-8c67-4d2a422a5ffb | 3 |
| 798408 | purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Aplisol] | SBD | 33ad349a-2969-4591-8c67-4d2a422a5ffb | 3 |
| 313532 | purified protein derivative of tuberculin 50 UNT/ML Injectable Solution | SCD | 33ad349a-2969-4591-8c67-4d2a422a5ffb | 3 |
| 798408 | Aplisol 5 UNT per 0.1 ML Injectable Solution | SY | 33ad349a-2969-4591-8c67-4d2a422a5ffb | 3 |
| 798408 | Aplisol 50 UNT/ML Injectable Solution | SY | 33ad349a-2969-4591-8c67-4d2a422a5ffb | 3 |
| 313532 | purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable Solution | SY | 33ad349a-2969-4591-8c67-4d2a422a5ffb | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42023-104-01 | 42023010401 | 1 VIAL in 1 CARTON (42023-104-01) / 1 mL in 1 VIAL | 1 vial | 2008-04-25 | 0000-00-00 | No | No | Current |
| 42023-104-05 | 42023010405 | 1 VIAL in 1 CARTON (42023-104-05) / 5 mL in 1 VIAL | 1 vial | 2008-04-25 | 0000-00-00 | No | No | Current |