Prescription drug · ANDA
Phenylephrine Hydrochloride NDC 75907-129
Phenylephrine hydrochloride 25 mg/mL · Solution/ drops · Ophthalmic · Dr.Reddy's Laboratories Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-129-07 | 7590701290775907012907 | 1 BOTTLE, DROPPER in 1 CARTON (75907-129-07) / 2 mL in 1 BOTTLE, DROPPERMarketed from Jan 14, 2025 |
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)
- Phenylephrine Hydrochloride
- Generic name (nonproprietary)
- phenylephrine hydrochloride
- Active ingredients
- Phenylephrine hydrochloride — 25 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Dr.Reddy's Laboratories Inc.,NDC labeler code 75907
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218129
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 75907-129_1ac5cf56-b9c6-af78-0d96-22c38a182575SPL ID 1ac5cf56-b9c6-af78-0d96-22c38a182575SPL set ID 869917f1-ae26-40cd-d332-5a31a796b877RxCUI 1234571, 1234579UNII 04JA59TNSJUPC 0375907130236
- Pharmacologic class
- alpha-1 Adrenergic Agonist
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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N475907012907followed by a unit qualifier and the quantityPackage 75907-0129-07. 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)
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 75907-129
- What is NDC 75907-129?
- 75907-129 is the product NDC for Phenylephrine Hydrochloride, Phenylephrine hydrochloride 25 mg/mL solution/ drops, listed with the FDA by Dr.Reddy's Laboratories Inc.,. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phenylephrine Hydrochloride.
- What is the active ingredient?
- Phenylephrine hydrochloride.
- Who is the labeler?
- Dr.Reddy's Laboratories Inc.,, NDC labeler code 75907. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Phenylephrine Hydrochloride?
- 107 other product NDCs are listed under this name. See all Phenylephrine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phenylephrine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | First Nation Group, LLC | 81469-168 | 81469-0168-0281469-0168-15 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/mL | Solution/ dropsOphthalmic | First Nation Group, LLC | 81469-169 | 81469-0169-05 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Fresenius Kabi USA, LLC | 65219-388 | 65219-0388-01 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Caplin Steriles Limited | 65145-115 | 65145-0115-25 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 50 mg/5mL | InjectionIntravenous | Caplin Steriles Limited | 65145-116 | 65145-0116-0165145-0116-10 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/10mL | InjectionIntravenous | Caplin Steriles Limited | 65145-117 | 65145-0117-01 |
| phenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-358 | 36000-0358-25 |
| phenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-360 | 36000-0360-10 |
| phenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-362 | 36000-0362-05 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Method Pharmaceuticals, LLC | 58657-851 | 58657-0851-26 |
Other NDCs under ANDA 218129
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 |
|---|---|---|---|---|
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-593 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-594 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-680 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/mL | Solution/ dropsOphthalmic | Dr.Reddy's Laboratories Inc., | 75907-130 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | Dr.Reddy's Laboratories Inc., | 75907-324 |