Dysport
- Product NDC
- 0299-5962
- 11-digit product format
- 002995962
- Labeler code
- 0299
- Product ID
- 0299-5962_253b9c91-ded3-b0b3-e063-6294a90a669a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Botulinum Toxin Type A
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Galderma Laboratories, L.P.
- Application
- BLA125274
- Marketing category
- BLA
- Marketing start
- 2009-11-02
- Substance
- BOTULINUM TOXIN TYPE A
- Active strength
- 300 U/1
- Pharmacologic classes
- Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dysport
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BOTULINUM TOXIN TYPE A | 300 U/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | E211KPY694 |
| Rxcui | 1789956, 1789958 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0299-5962-01 | Dysport | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 12 |
| 0299-5962-01 | Dysport | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 12 |
| 0299-5962-30 | Dysport | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 12 |
| 0299-5962-30 | Dysport | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Botulinum Toxin Type A | ACTIVE INGREDIENT | E211KPY694 | DYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GALDERMA LABORATORIES, L.P.] | 1 | |
| ABOBOTULINUMTOXINA | ACTIVE MOIETY | E211KPY694 | DYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GALDERMA LABORATORIES, L.P.] | 1 | |
| albumin human | INACTIVE INGREDIENT | ZIF514RVZR | DYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GALDERMA LABORATORIES, L.P.] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | DYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GALDERMA LABORATORIES, L.P.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0299-5962 | DYSPORT (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GALDERMA LABORATORIES, L.P.] | 12 | Current NDC, Legacy NDC, 4 package rows | 20241027_71313a04-1349-4c26-b840-a39e4a3ddaed.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0299-5962-01 | 00299596201 | 1 VIAL in 1 CARTON (0299-5962-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2009-11-02 | 0000-00-00 | Yes | No | Current |
| 0299-5962-30 | 00299596230 | 1 VIAL in 1 CARTON (0299-5962-30) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2009-11-02 | 0000-00-00 | No | No | Current |