What is NDC 45802-758?

45802-758 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 12.5 mg/1 suppository, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Promethazine Hydrochloride?

116 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Promethazine Hydrochloride NDC 45802-758

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-758Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0758Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
45802-758-30	4580207583045802075830	12 BLISTER PACK in 1 CARTON (45802-758-30) / 1 SUPPOSITORY in 1 BLISTER PACK (45802-758-00)Marketed from Jun 27, 2006

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): Promethazine Hydrochloride
Generic name (nonproprietary): promethazine hydrochloride
Active ingredients: Promethazine hydrochloride — 12.5 mg/1
Dosage form: Suppository
Route: Rectal
Labeler: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040500
Marketing start: Jun 27, 2006
Listing expires: Dec 31, 2027
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 45802-758_fbb870d0-561a-4468-bd5a-1723727eb1cdSPL ID fbb870d0-561a-4468-bd5a-1723727eb1cd
Pharmacologic class: Phenothiazine

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N445802075830 followed by a unit qualifier and the quantity

Package 45802-0758-30. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 45802-758

What is NDC 45802-758?: 45802-758 is the product NDC for Promethazine Hydrochloride, Promethazine hydrochloride 12.5 mg/1 suppository, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Promethazine Hydrochloride.
What is the active ingredient?: Promethazine hydrochloride.
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 Promethazine Hydrochloride?: 116 other product NDCs are listed under this name. See all Promethazine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Promethazine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Northwind Health Company, LLC	82868-115	82868-0115-20
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Coupler LLC	67046-1043	67046-1043-03
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-070	87441-0070-01
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1854	00121-1854-16
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	REMEDYREPACK INC.	70518-4419	70518-4419-00
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SyrupOral	Xttrium Laboratories, Inc.	0116-4023	00116-4023-16
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SyrupOral	Atlantic Biologicals Corp.	17856-4023	17856-4023-01
Promethazine Hydrochloride	Promethazine hydrochloride 50 mg/1	TabletOral	Coupler LLC	67046-1447	67046-1447-03
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	Kesin Pharma Corporation	81033-016	81033-0016-50
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	TabletOral	Cardinal Health 107, LLC	55154-3373	55154-3373-00

All 117 Promethazine Hydrochloride NDCs

Other NDCs under ANDA 040500

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 040500
Product	Strength	Form · route	Labeler	Product NDC
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	SuppositoryRectal	PD-Rx Pharmaceuticals, Inc.	43063-060
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	SuppositoryRectal	Padagis Israel Pharmaceuticals Ltd	45802-759
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	SuppositoryRectal	A-S Medication Solutions	50090-2747
Promethazine Hydrochloride	Promethazine hydrochloride 12.5 mg/1	SuppositoryRectal	Asclemed USA, Inc.	76420-388
Promethazine Hydrochloride	Promethazine hydrochloride 25 mg/1	SuppositoryRectal	Asclemed USA, Inc.	76420-389