What is NDC 54348-148?

54348-148 is the product NDC for Misoprostol, Misoprostol 200 ug/1 tablet, listed with the FDA by PharmPak, Inc.. It has 8 package NDCs, shown above in 10- and 11-digit form.

PharmPak, Inc., NDC labeler code 54348. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Misoprostol?

22 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Misoprostol NDC 54348-148 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54348-148Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54348-0148Add 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
54348-148-00	5434801480054348014800	1 BOTTLE in 1 BOX (54348-148-00) / 1 TABLET in 1 BOTTLEMarketed from Jul 10, 2019
54348-148-01	5434801480154348014801	1 BOTTLE in 1 BOX (54348-148-01) / 1 TABLET in 1 BOTTLEMarketed from Jul 10, 2019
54348-148-02	5434801480254348014802	1 BOTTLE in 1 BOX (54348-148-02) / 2 TABLET in 1 BOTTLEMarketed from Jul 10, 2019
54348-148-03	5434801480354348014803	1 BOTTLE in 1 BOX (54348-148-03) / 3 TABLET in 1 BOTTLEMarketed from Jul 10, 2019
54348-148-04	5434801480454348014804	1 BOTTLE in 1 BOX (54348-148-04) / 4 TABLET in 1 BOTTLEMarketed from Jul 10, 2019
54348-148-06	5434801480654348014806	1 BOTTLE in 1 BOX (54348-148-06) / 6 TABLET in 1 BOTTLEMarketed from Jul 10, 2019
54348-148-08	5434801480854348014808	1 BOTTLE in 1 BOX (54348-148-08) / 8 TABLET in 1 BOTTLEMarketed from Jul 10, 2019
54348-148-09	5434801480954348014809	1 BOTTLE in 1 BOX (54348-148-09) / 9 TABLET in 1 BOTTLEMarketed from Jul 10, 2019

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): Misoprostol
Generic name (nonproprietary): misoprostol
Active ingredients: Misoprostol — 200 ug/1
Dosage form: Tablet
Route: Oral
Labeler: PharmPak, Inc.NDC labeler code 54348
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091667
Marketing start: Jul 10, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Synthetic (Chemical structure)
Identifiers: Product ID 54348-148_ea92d79f-b58c-2ad8-e053-2a95a90acafbSPL ID ea92d79f-b58c-2ad8-e053-2a95a90acafbSPL set ID b07b3dfc-1cb5-484c-be11-8d14c89c794fRxCUI 317128UNII 0E43V0BB57
Pharmacologic class: Prostaglandin E1 Analog

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N454348014800 followed by a unit qualifier and the quantity

Package 54348-0148-00. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 54348-148

What is NDC 54348-148?: 54348-148 is the product NDC for Misoprostol, Misoprostol 200 ug/1 tablet, listed with the FDA by PharmPak, Inc.. It has 8 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Misoprostol.
What is the active ingredient?: Misoprostol.
Who is the labeler?: PharmPak, Inc., NDC labeler code 54348. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Misoprostol?: 22 other product NDCs are listed under this name. See all Misoprostol 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 Misoprostol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Misoprostol	Misoprostol 200 ug/1	TabletOral	Cardinal Health 107, LLC	55154-2145	55154-2145-00
Misoprostol	Misoprostol 200 ug/1	TabletOral	AvPAK	50268-555	50268-0555-60
Misoprostol	Misoprostol 200 ug/1	TabletOral	GenBioPro, Inc.	43393-024	43393-0024-04
Misoprostol	Misoprostol 200 ug/1	TabletOral	GenBioPro, Inc.	43393-200	43393-0200-4843393-0200-60
Misoprostol	Misoprostol 100 ug/1	TabletOral	American Health Packaging	60687-735	60687-0735-01
Misoprostol	Misoprostol 200 ug/1	TabletOral	American Health Packaging	60687-746	60687-0746-01
Misoprostol	Misoprostol 200 ug/1	TabletOral	GenBioPro, Inc.	43393-023	43393-0023-04
Misoprostol	Misoprostol 100 ug/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3762	68071-3762-0368071-3762-09
Misoprostol	Misoprostol 100 ug/1	TabletOral	ANI Pharmaceuticals, Inc.	70954-443	70954-0443-1070954-0443-20
Misoprostol	Misoprostol 200 ug/1	TabletOral	ANI Pharmaceuticals, Inc.	70954-444	70954-0444-1070954-0444-20

All 23 Misoprostol NDCs

Other NDCs under ANDA 091667

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

FDA NDC Directory listings under ANDA 091667
Product	Strength	Form · route	Labeler	Product NDC
Misoprostol	Misoprostol 100 ug/1	TabletOral	Novel Laboratories, Inc.	40032-160
Misoprostol	Misoprostol 200 ug/1	TabletOral	Novel Laboratories, Inc.	40032-161
Misoprostol	Misoprostol 100 ug/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-160
Misoprostol	Misoprostol 200 ug/1	TabletOral	Lupin Pharmaceuticals,Inc.	43386-161
Misoprostol	Misoprostol 200 ug/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4843