Prescription drug · ANDA
Erythromycin NDC 45802-966
Erythromycin 20 mg/g · Gel · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-966-94 | 4580209669445802096694 | 1 TUBE in 1 CARTON (45802-966-94) / 30 g in 1 TUBEMarketed from Sep 8, 2008 | |
| 45802-966-96 | 4580209669645802096696 | 1 TUBE in 1 CARTON (45802-966-96) / 60 g in 1 TUBEMarketed from Jun 12, 2008 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Erythromycin
- Generic name (nonproprietary)
- erythromycin
- Active ingredients
- Erythromycin — 20 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 063211
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
- Identifiers
- Product ID 45802-966_4dc0587a-23b1-43b0-a1a5-18a8acbbede1SPL ID 4dc0587a-23b1-43b0-a1a5-18a8acbbede1SPL set ID dd64459e-c88f-4ca8-b63b-fb96377a3921RxCUI 310152UNII 63937KV33D
- Pharmacologic class
- Macrolide Antimicrobial; Macrolide
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N445802096694followed by a unit qualifier and the quantityPackage 45802-0966-94. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Erythromycin Topical Gel USP, 2% is indicated for the topical treatment of acne vulgaris.
Excerpt only. Read the full label for complete information.
About NDC 45802-966
- What is NDC 45802-966?
- 45802-966 is the product NDC for Erythromycin, Erythromycin 20 mg/g gel, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Erythromycin.
- What is the active ingredient?
- Erythromycin.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Erythromycin?
- 68 other product NDCs are listed under this name. See all Erythromycin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Erythromycin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Sentiss Pharmaceuticals LLC | 70244-031 | 70244-0031-0170244-0031-02 |
| Erythromycin | Erythromycin 333 mg/1 | Tablet, Delayed releaseOral | Torrent Pharmaceuticals Limited | 13668-587 | 13668-0587-0113668-0587-0513668-0587-30 |
| erythromycin | Erythromycin 250 mg/1 | Capsule, Delayed release pelletsOral | Dr. Reddy's Labratories Inc. | 75907-076 | 75907-0076-01 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | ST. MARY'S MEDICAL PARK PHARMACY | 60760-670 | 60760-0670-35 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Redpharm Drug | 67296-2128 | 67296-2128-03 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-3992 | 68071-3992-02 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | ARMAS PHARMACEUTICALS INC. | 72485-670 | 72485-0670-3172485-0670-35 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Fera Pharmaceuticals, LLC | 48102-057 | 48102-0057-11 |
| Erythromycin | Erythromycin 250 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-397 | 46708-0397-3046708-0397-3146708-0397-91 |
| Erythromycin | Erythromycin 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-398 | 46708-0398-3046708-0398-3146708-0398-91 |
Other NDCs under ANDA 063211
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Erythromycin | Erythromycin 20 mg/g | GelTopical | Bryant Ranch Prepack | 63629-8652 |
| Erythromycin | Erythromycin 20 mg/g | GelTopical | Bryant Ranch Prepack | 63629-8653 |
| Erythromycin | Erythromycin 20 mg/g | GelTopical | Bryant Ranch Prepack | 72162-1444 |