NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7165Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7165Add 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 NDC11-digit (billing)PackageCopy
0904-7165-07009047165070090471650730 BLISTER PACK in 1 CARTON (0904-7165-07) / 1 TABLET in 1 BLISTER PACKMarketed from Nov 30, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Aminocaproic acid
Generic name (nonproprietary)
aminocaproic acid
Active ingredients
Aminocaproic acid — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212492
Marketing start
Listing expires
Other FDA classes
Decreased Fibrinolysis (Physiologic effect)
Identifiers
Product ID 0904-7165_52582352-b804-4329-bf74-d5297fb778dbSPL ID 52582352-b804-4329-bf74-d5297fb778dbSPL set ID 2612ee97-1723-40f2-99e6-3a736f63200fRxCUI 197351UNII U6F3787206
Pharmacologic class
Antifibrinolytic Agent

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

N400904716507 followed by a unit qualifier and the quantity

Package 00904-7165-07. 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)

INDICATIONS AND USAGE Aminocaproic acid tablets are useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usualIy a norma…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-7165

What is NDC 0904-7165?
0904-7165 is the product NDC for Aminocaproic acid, Aminocaproic acid 500 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Aminocaproic acid.
What is the active ingredient?
Aminocaproic acid.
Who is the labeler?
Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Aminocaproic acid?
36 other product NDCs are listed under this name. See all Aminocaproic acid 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 Aminocaproic acid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Aminocaproic AcidAminocaproic acid 500 mg/1TabletOralRISING PHARMA HOLDINGS, INC.16571-32616571-0326-03
Aminocaproic AcidAminocaproic acid 1000 mg/1TabletOralRISING PHARMA HOLDINGS, INC.16571-32716571-0327-03
Aminocaproic AcidAminocaproic acid .25 g/mLSolutionOralFlorida Pharmaceutical Products, LLC71921-17571921-0175-08
Aminocaproic AcidAminocaproic acid .25 g/mLSolutionOralApozeal Pharmaceuticals Inc.83745-29483745-0294-08
Aminocaproic acidAminocaproic acid .25 g/mLSolutionOralNovadoz Pharmaceuticals LLC72205-03272205-0032-7172205-0032-72
Aminocaproic AcidAminocaproic acid .25 g/mLSolutionOralVitruvias Therapeutics69680-11469680-0114-08
Aminocaproic acidAminocaproic acid 1000 mg/1TabletOralNovadoz Pharmaceuticals LLC72205-28672205-0286-30
Aminocaproic AcidAminocaproic acid 500 mg/1TabletOralAmerican Health Packaging60687-73960687-0739-25
Aminocaproic AcidAminocaproic acid 500 mg/1TabletOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-79824658-0798-30
Aminocaproic AcidAminocaproic acid 1000 mg/1TabletOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-79924658-0799-30

All 37 Aminocaproic acid NDCs

Other NDCs under ANDA 212492

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

FDA NDC Directory listings under ANDA 212492
ProductStrengthForm · routeLabelerProduct NDC
Aminocaproic acidAminocaproic acid 500 mg/1TabletOralAmneal Pharmaceuticals LLC69238-1637

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