Neomycin and Polymyxin B Sulfates and Hydrocortisone
- Product NDC
- 61314-641
- 11-digit product format
- 613140641
- Labeler code
- 61314
- Product ID
- 61314-641_15cc1b8f-5a7f-4cfb-8c65-9d35f7c0f30f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- neomycin sulfate, polymyxin b sulfate and hydrocortisone
- Dosage form
- SUSPENSION
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc
- Application
- ANDA062874
- Marketing category
- ANDA
- Marketing start
- 2003-05-09
- Substance
- HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- Active strength
- 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Neomycin and Polymyxin B Sulfates and Hydrocortisone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 10 mg/mL |
| NEOMYCIN SULFATE | 3.5 mg/mL |
| POLYMYXIN B SULFATE | 10000 [USP'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ, 057Y626693, 19371312D4 |
| Rxcui | 204874 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61314-641-75 | Neomycin and Polymyxin B Sulfates and Hydrocortisone | 7.5 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 7.5 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| NEOMYCIN SULFATE | ACTIVE INGREDIENT | 057Y626693 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| POLYMYXIN B SULFATE | ACTIVE INGREDIENT | 19371312D4 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| NEOMYCIN | ACTIVE MOIETY | I16QD7X297 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| POLYOXYL 40 STEARATE | INACTIVE INGREDIENT | 13A4J4NH9I | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| THIMEROSAL | INACTIVE INGREDIENT | 2225PI3MOV | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [FALCON PHARMACEUTICALS, LTD.] | 4 | |
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| NEOMYCIN SULFATE | ACTIVE INGREDIENT | 057Y626693 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| NEOMYCIN SULFATE | ACTIVE INGREDIENT | 057Y626693 | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYMYXIN B SULFATE | ACTIVE INGREDIENT | 19371312D4 | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYMYXIN B SULFATE | ACTIVE INGREDIENT | 19371312D4 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| NEOMYCIN | ACTIVE MOIETY | I16QD7X297 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| NEOMYCIN | ACTIVE MOIETY | I16QD7X297 | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYOXYL 40 STEARATE | INACTIVE INGREDIENT | 13A4J4NH9I | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYOXYL 40 STEARATE | INACTIVE INGREDIENT | 13A4J4NH9I | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| THIMEROSAL | INACTIVE INGREDIENT | 2225PI3MOV | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
| THIMEROSAL | INACTIVE INGREDIENT | 2225PI3MOV | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NEOMYCIN, POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [STAT RX USA LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61314-641 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION [SANDOZ INC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20220216_96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d.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 |
|---|
| 61314-641-75 | 61314064175 | 7.5 mL in 1 BOTTLE, PLASTIC (61314-641-75) | 7.5 ml | 2003-05-09 | 0000-00-00 | No | No | Current |