BOTOX
- Product NDC
- 0023-3921
- 11-digit product format
- 000233921
- Labeler code
- 0023
- Product ID
- 0023-3921_7365af65-15e0-4fc1-aa6a-aaec5a43c468
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- onabotulinumtoxinA
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRADERMAL; INTRAMUSCULAR
- Labeler
- Allergan, Inc.
- Application
- BLA103000
- Marketing category
- BLA
- Marketing start
- 2010-01-11
- Substance
- BOTULINUM TOXIN TYPE A
- Active strength
- 200 [USP'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
- BOTOX
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BOTULINUM TOXIN TYPE A | 200 [USP'U]/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | E211KPY694 |
| Rxcui | 860192, 860195, 897366, 897368 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0023-3921-02 | BOTOX | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 61 |
| 0023-3921-02 | BOTOX | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 61 |
| 0023-3921-03 | BOTOX | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 61 |
| 0023-3921-03 | BOTOX | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 61 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| botulinum toxin type A | ACTIVE INGREDIENT | E211KPY694 | BOTOX (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.
] | 24 | |
| botulinum toxin type A | ACTIVE MOIETY | E211KPY694 | BOTOX (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.
] | 24 | |
| Albumin (Human) | INACTIVE INGREDIENT | ZIF514RVZR | BOTOX (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.
] | 24 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | BOTOX (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.
] | 24 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0023-3921 | BOTOX (ONABOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALLERGAN, INC.] | 59 | Current NDC, Legacy NDC, 4 package rows | 20241101_33d066a9-34ff-4a1a-b38b-d10983df3300.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 |
|---|
| 0023-3921-02 | 00023392102 | 1 VIAL in 1 CARTON (0023-3921-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2010-01-11 | 0000-00-00 | No | No | Current |
| 0023-3921-03 | 00023392103 | 1 VIAL in 1 CARTON (0023-3921-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2010-01-11 | 0000-00-00 | No | No | Current |